Heart Failure Score Research Articles

North Central Cancer Treatment Group N10C2 (Alliance): a double-blind placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.

Hot flashes are a common symptom in breast cancer survivors that can negatively impact quality of life. Preliminary data suggested that magnesium might be used as an effective low-cost treatment of hot flashes with minimal adverse effects. A four-arm, double-blind, placebo-controlled, randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome hot flashes were randomized into treatment groups of magnesium oxide 800 or 1,200 mg daily or corresponding placebo groups at a 2:2:(1:1) ratio. Hot flash frequency and hot flash score (number × mean severity) were measured using a validated hot flash diary. A 1-week baseline period preceded initiation of study medication. The primary endpoint was intrapatient difference in mean hot flash score between baseline and treatment periods, comparing each magnesium group with the combined placebo groups using a gatekeeping procedure. Results were analyzed using repeated-measures and growth curve models on weekly hot flash scores based on a modified intent-to-treat principle. Two hundred eighty-nine women enrolled between December 2011 and March 2013. Study groups were well balanced for baseline characteristics. Mean hot flash scores, mean hot flash frequencies, and associated changes during the treatment period were similar for each group. An increased incidence of diarrhea and a corresponding lower incidence of constipation were reported in magnesium arms compared with placebo. No statistically significant difference in other toxicities or quality-of-life measures was observed. The results of this trial do not support the use of magnesium oxide for hot flashes.

Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial.

BackgroundAcute exacerbation is a common cause of hospitalization in patients with chronic heart failure, and coronary heart disease is the most common cause. Shenfu injection, a Traditional Chinese Medicine injection, widely used in the adjuvant treatment of patients with acute exacerbation of chronic heart failure, shows some treatment effect in improving the symptoms and the quality of life, but it lacks the rigorous clinical evaluation of research reports. This paper describes the protocol for the clinical assessment of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure.MethodsThis protocol adopts the design of a prospective, randomized, multicenter, blind imitation, placebo-controlled trial to assess the efficacy and safety of Shenfu injection loading in the treatment of patients with acute exacerbation of chronic heart failure due to coronary heart disease. The research will be carried out in 12 hospitals in China and is expected to enroll 160 inpatients with acute exacerbation of chronic heart failure due to coronary heart disease (yang and qi deficiency syndrome). On the basis of the conventional therapy of western medicine, patients will be randomized to either the treatment group (100 ml 5% glucose injection + 50 ml Shenfu injection) or the control group (150 ml 5% glucose injection) for 7 ± 1 days and follow-up for 28 ± 3 days. The primary outcomes are New York Heart Association cardiac function classification and Traditional Chinese Medicine syndromes. The secondary outcomes are left ventricular ejection fraction, brain natriuretic peptide level, Lee’s heart failure score, 6-minute walking distance, and the incidence and readmission rate of cardiovascular events (including the emergency rate due to acute exacerbation of chronic heart failure).DiscussionThis trial will assess the effect of loading Shenfu injection in the treatment of patients with acute exacerbation of chronic heart failure caused by coronary heart disease (yang-qi deficiency syndrome) on the symptoms and signs of heart failure, exercise tolerance, and other aspects, and observe its influence on the short-term prognosis with follow-up. The results of the study will provide clinical research evidence for application of Shenfu injection in the treatment.Trial registrationThis trial was registered on 26 December 2012 at the Chinese Clinical Trials Register (Identifier: ChiCTR-TRC-12002857).Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0729-7) contains supplementary material, which is available to authorized users.

Abstract P3-12-02: Lifestyle interventions combined with acupuncture-like transcutaneous electrical nerve stimulation in managing vasomotor symptoms induced by breast cancer treatment: Results of a phase 2 randomized controlled trial

Abstract Background: Women with breast cancer can experience significant treatment induced vasomotor symptoms (TIVS). Non-hormonal strategies for TIVS (e.g. acupuncture, Venlafaxine) provide some relief but may be intolerable because of the invasive nature of the treatment and possible side effects. As such, women often prefer lifestyle strategies (LS) that can be self-administered. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is a non-invasive needleless technique that uses specific electrical parameters to stimulate selected acupoints to achieve clinical response with minimal toxicity. ALTENS can be administered with minimal training. It is amenable to quality assurance and can allow for self treatment by women. This study aimed to evaluate the efficacy of ALTENS in addition to LS in relieving TIVS in women with breast cancer. Methods: Eligible subjects were postmenopausal women with Stages 0-3 breast cancer who had completed cancer treatment and were experiencing hot flashes for ≥ one month with a Hot Flash Score (HFS) ≥15 in one week prior to consent. Anti-estrogen therapy was permitted. Non-hormonal drug therapies were prohibited. Subjects were randomized to either LS (control) or LS with concurrent ALTENS (combined). LS consisted of standardized lifestyle strategies (e.g. environmental control, managing hot flash triggers) counseling delivered by a specially trained nurse practitioner at week 0 with reinforcing counseling at weeks 12 and 24. ALTENS was given twice weekly for 12 treatments over an 8-week period. The HFS, Hot Flash Related Daily Interference Scale and the Short Form version 2 health survey were administered at weeks 0, 12 and 24. Heart rate variability was measured at weeks 0 and 12. The primary study endpoint was the number of responders, defined as women who had > 50% reduction in their HFS between weeks 0 and 12. Results: 71 eligible subjects with a median age of 52 (range: 40-87) were randomized to combined arm (n=36) and control (n=35). At 12 weeks there were 11 (30.6%) responders in the combined arm versus 2 (5.7%) in the control (p=0.012).The results at 24 weeks were 14 versus 4, respectively (p=0.013). Arms were balanced for anti-estrogen use. Two subjects chose to discontinue ALTENS after experiencing symptoms improvement. There were no serious adverse events. Conclusion: ALTENS in combination with lifestyle strategies is a promising non-pharmacologic approach that showed improvement in managing treatment induced vasomotor symptoms in women with breast cancer. Our trial results support its evaluation in phase 3 studies. Citation Format: Margaret Forbes, Raimond Wong, Stephen M Sagar, Jim A Julian, Mark N Levine, Joseph Hayward. Lifestyle interventions combined with acupuncture-like transcutaneous electrical nerve stimulation in managing vasomotor symptoms induced by breast cancer treatment: Results of a phase 2 randomized controlled trial [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-12-02.

Heart failure in a cohort of patients with chronic kidney disease: the GCKD study.

Background and AimsChronic kidney disease (CKD) is a risk factor for development and progression of heart failure (HF). CKD and HF share common risk factors, but few data exist on the prevalence, signs and symptoms as well as correlates of HF in populations with CKD of moderate severity. We therefore aimed to examine the prevalence and correlates of HF in the German Chronic Kidney Disease (GCKD) study, a large observational prospective study.Methods and ResultsWe analyzed data from 5,015 GCKD patients aged 18–74 years with an estimated glomerular filtration rate (eGFR) of <60 ml/min/1.73m² or with an eGFR ≥60 and overt proteinuria (>500 mg/d). We evaluated a definition of HF based on the Gothenburg score, a clinical HF score used in epidemiological studies (Gothenburg HF), and self-reported HF. Factors associated with HF were identified using multivariable adjusted logistic regression. The prevalence of Gothenburg HF was 43% (ranging from 24% in those with eGFR >90 to 59% in those with eGFR<30 ml/min/1.73m2). The corresponding estimate for self-reported HF was 18% (range 5%-24%). Lower eGFR was significantly and independently associated with the Gothenburg definition of HF (p-trend <0.001). Additional significantly associated correlates included older age, female gender, higher BMI, hypertension, diabetes mellitus, valvular heart disease, anemia, sleep apnea, and lower educational status.ConclusionsThe burden of self-reported and Gothenburg HF among patients with CKD is high. The proportion of patients who meet the criteria for Gothenburg HF in a European cohort of patients with moderate CKD is more than twice as high as the prevalence of self-reported HF. However, because of the shared signs, symptoms and medications of HF and CKD, the Gothenburg score cannot be used to reliably define HF in CKD patients. Our results emphasize the need for early screening for HF in patients with CKD.

Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials.

Heart failure with preserved ejection fraction (HFPEF) is common and characterized by exercise intolerance and lack of proven effective therapies. Exercise training has been shown to be effective in improving cardiorespiratory fitness (CRF) in patients with systolic heart failure. In this meta-analysis, we aim to evaluate the effects of exercise training on CRF, quality of life, and diastolic function in patients with HFPEF. Randomized controlled clinical trials that evaluated the efficacy of exercise training in patients with HFPEF were included in this meta-analysis. Primary outcome of the study was change in CRF (measured as change in peak oxygen uptake). Effect of exercise training on quality of life (estimated using Minnesota living with heart failure score), and left ventricular systolic and diastolic function was also assessed. The study included 276 patients who were enrolled in 6 randomized controlled trials. In the pooled data analysis, patients with HFPEF undergoing exercise training had significantly improved CRF (mL/kg per min; weighted mean difference, 2.72; 95% confidence interval, 1.79-3.65) and quality of life (weighted mean difference, -3.97; 95% confidence interval, -7.21 to -0.72) when compared with the control group. However, no significant change was observed in the systolic function (EF-weighted mean difference, 1.26; 95% confidence interval, -0.13% to 2.66%) or diastolic function (E/A-weighted mean difference, 0.08; 95% confidence interval, -0.01 to 0.16) with exercise training in patients with HFPEF. Exercise training in patients with HFPEF is associated with an improvement in CRF and quality of life without significant changes in left ventricular systolic or diastolic function.

Statin withdrawal in stable heart failure patients results in no change in clinical status or quality of life

Background: The current role of statins in heart failure with reduced ejection fraction (HFREF) is unclear. We therefore sought to investigate the effect of statin withdrawal in such patients, while taking optimal doses of proven heart failure medications. Methods: This was a prospective, randomised, single-blind, placebo-controlled, two-arm cross-over trial. Participants were randomised to either statin continuation (“statin on”) or unmatched placebo (“statin off”) and crossed over at 3 months. Study statin was the participants’ regular statin at their usual dose. Standard HF clinical status and quality of life (QoL) endpoints were evaluated. Groups were compared using Student's paired t-test. Results: The 13 study participants had a mean age of 64±11 years, 62% male, duration of HF was 7.7±5.7 years, and mean ejection fraction was 38.1±10.4%. Aetiology of HF was idiopathic (12) and ischaemic (1). Compared with taking statin, withdrawal of statin resulted in no significant changes in plasma brain natriuretic peptide (BNP, statin on: 130±49 vs statin off: 129±50ng/L, p=0.92) and no change in 6 minute walk distance (statin on: 455±52 vs statin off: 450±55m, p =0.80). No changes in QoL measures were observed, including Minnesota Living with HF score (statin on: 32±7 vs statin off: 31±9, p=0.41), Cardiac Depression Score (statin on: 77±6 vs statin off: 81±6, p=0.44) and SF-36 (statin on: 93±5 vs statin off: 94±5, p=0.25). Conclusions: Withdrawal of statins in stable HFREF patients receiving optimal background heart failure therapy did not alter HF clinical status including plasma BNP levels, submaximal exercise capacity or quality of life measures.

Clinical scores in chronic heart failure: does an ideal score exist?

Numerous prognostic markers have shown to be predictive of patient outcome in heart failure (HF). The recent guidelines of the European Society of Cardiology for the diagnosis and treatment of acute and chronic HF have identified as many as 57 individual markers in patients with HF, including demographic data, etiology, comorbidities, clinical, radiological, hemodynamic, echocardiographic and biochemical parameters. If more accurate risk stratification is required, several scoring systems have been proposed. This article reviews scoring systems for HF prognostication. Although most of the models include readily available clinical information, usually NYHA functional class, left ventricular ejection fraction (LVEF) and comorbidities, quite a few of them comprise Doppler echocardiographic variables, other than LVEF, and circulating levels of natriuretic peptides. In order to achieve a better prediction of the outcome, an ideal score should be based on a comprehensive Doppler echocardiographic examination, the assessment of circulating biomarkers, and a more objective evaluation of exercise tolerance.

The predictive capacity and additional prognostic power of N-terminal pro-B-type natriuretic peptide in Chinese elderly with chronic heart failure.

ObjectiveThis study was conducted to research the prognostic utility of N-terminal pro-B-type natriuretic peptide (NT-proBNP), compare the utility of the Seattle Heart Failure Score (SHFS) with NT-proBNP, develop a risk-evaluation model based on NT-proBNP, assess the associations of NT-proBNP with patient characteristics, and screen for decisive factors of NT-proBNP in Chinese elderly with chronic heart failure (CHF).Patients and methodsThere were 306 patients (≥60 years) with CHF chosen as study subjects. Each one received an assessment of NT-proBNP on serum. The end point was all-cause mortality during a mean follow-up period of 471 days.ResultsSubjects had a median age of 85 (60–100) years, a median NT-proBNP of 1,743.4 pg/mL, and a median SHFS of 1.87. During the follow-up period, 104 deaths occurred. NT-proBNP was significantly related to mortality (odds ratio 1.603, 95% confidence interval 1.407–1.826; P<0.001) and the significance persisted after full adjustment (odds ratio 1.282, 95% confidence interval 1.103–1.489; P=0.001). Age, New York Heart Association class IV CHF, plasma albumin, and neutrophils/lymphocytes were also independent predictors for mortality (P<0.05 for all). NT-proBNP and the SHFS showed similar predictive capacities (0.736 versus 0.796, P=0.105). The addition of NT-proBNP to the SHFS (0.818 versus 0.796, P=0.168) generated marginal growth in the c-statistic. The model based on NT-proBNP consisting of all selected predictors in this study, including age, New York Heart Association class IV CHF, plasma albumin, neutrophils/lymphocytes, and NT-proBNP, had a moderately higher c-statistic compared with the SHFS (0.846 versus 0.796, P=0.066). NT-proBNP was bound with the SHFS (r=0.500, P<0.001). Characteristics regarding general condition, inflammation, and cardiac and renal function were the decisive factors of NT-proBNP (P<0.05 for all).ConclusionAs a comprehensive representation of the patient characteristics described earlier, NT-proBNP values provided significant prognostic power similar to the SHFS in Chinese elderly with CHF. A novel model based on NT-proBNP could offer help for risk stratification.

Long-term functional benefits of human embryonic stem cell-derived cardiac progenitors embedded into a fibrin scaffold

Cardiac-committed cells and biomimetic scaffolds independently improve the therapeutic efficacy of stem cells. In this study we tested the long-term effects of their combination. Eighty immune-deficient rats underwent permanent coronary artery ligation. Five to 7 weeks later, those with an echocardiographically measured ejection fraction (EF) ≤55% were re-operated on and randomly allocated to receive a cell-free fibrin patch (n = 25), a fibrin patch loaded with 700,000 human embryonic stem cells (ESC) pre-treated to promote early cardiac differentiation (SSEA-1(+) progenitors [n = 30]), or to serve as sham-operated animals (n = 25). Left ventricular function was assessed by echocardiography at baseline and every month thereafter until 4 months. Hearts were then processed for assessment of fibrosis and angiogenesis and a 5-component heart failure score was constructed by integrating the absolute change in left ventricular end-systolic volume (LVESV) between 4 months and baseline, and the quantitative polymerase chain reaction (qPCR)-based expression of natriuretic peptides A and B, myosin heavy chain 7 and periostin. All data were recorded and analyzed in a blinded manner. The cell-treated group consistently yielded better functional outcomes than the sham-operated group (p = 0.002 for EF; p = 0.01 for LVESV). Angiogenesis in the border zone was also significantly greater in the cell-fibrin group (p = 0.006), which yielded the lowest heart failure score (p = 0.04 vs sham). Engrafted progenitors were only detected shortly after transplantation; no grafted cells were identified after 4 months. There was no teratoma identified. A fibrin scaffold loaded with ESC-derived cardiac progenitors resulted in sustained improvement in contractility and attenuation of remodeling without sustained donor cell engraftment. A paracrine effect, possibly on innate reparative responses, is a possible mechanism for this enduring effect.

Heart failure risk prediction in the Multi-Ethnic Study of Atherosclerosis.

Heart failure (HF) is a leading cause of mortality especially in older populations. Early detection of high-risk individuals is imperative for primary prevention. The purpose of this study was to develop a HF risk model from a population without clinical cardiac disease. The Multi-Ethnic Study of Atherosclerosis is a multicentre observational cohort study following 6814 subjects (mean age 62±10 years; 47% men) who were free of clinical cardiovascular disease at baseline. Median follow-up was 4.7 years. HF events developed in 176 participants. Cox proportional hazards models and regression coefficients were used to determine independent risk factors and generate a 5-year risk score for incident HF. Bootstrapping with bias correction was used for internal validation. Independent predictors for HF (HR, p value) were age (1.30 (1.10 to 1.50) per 10 years), male gender (2.27 (1.53 to 3.36)), current smoking (1.97 (1.15 to 3.36)), body mass index (1.40 (1.10 to 1.80) per 5 kg/m(2)), systolic blood pressure (1.10 (1.00 to 1.10) per 10 mm Hg), heart rate (1.30) (1.10 to 1.40) per 10 bpm), diabetes (2.27 (1.48 to 3.47)), N-terminal pro-B-type natriuretic peptide (NT proBNP) (2.48 (2.16 to 2.84) per unit log increment) and left ventricular mass index (1.40 (1.30 to 1.40) per 10 g/m(2)). A parsimonious model based on age, gender, body mass index, smoking status, systolic blood pressure, heart rate, diabetes and NT proBNP natriuretic peptide predicted incident HF risk with a c-statistic of 0.87. A clinical algorithm based on risk factors readily available in the primary care setting can used to identify individuals with high likelihood of developing HF without pre-existing cardiac disease.

Risk scores in end stage heart failure

Risk scores in end stage heart failure

Ambulatory Extra-Aortic Counterpulsation in Patients With Moderate to Severe Chronic Heart Failure

ObjectivesThe study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients. Background30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients. MethodsNew York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO2; 6 months only). ResultsTwelve men and 8 women (56.7 ± 7 years, 34 to 71 years of age) with ischemic (n = 7) or nonischemic (n = 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 ± 0.3 to 1.9 ± 0.7, p = 0.0005), MLWHF (63.6 ± 19.9 to 40.2 ± 23.2, p = 0.0005), and KCCQ scores (43.6 ± 21.1 to 65.6 ± 21.5, p = 0.0002), but not 6MWD (275.5 ± 64.0 to 296.4 ± 104.9, p = NS) or pVO2 (14.5 ± 3.6 to 13.1 ± 4.4, p = NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 ± 91.8, p = 0.0425). ConclusionsUse of C-Pulse in this population is feasible, appears safe, and improves functional status and QoL. A prospective, multicenter, randomized controlled trial is underway. (C-Pulse IDE Feasability Study-A Heart Assist System; NCT00815880)

Reasons why patients suffering from chronic heart failure at very high risk for death survive

BackgroundAn accurate prognostic stratification is essential for optimizing the clinical management and treatment decision-making of patients with chronic heart failure (HF). Among the best available models, we used the Cardiac and Comorbid Conditions HF (3C-HF) Score, to predict all-cause mortality in patients with CHF. Methods: we selected and characterized the subgroup of patients at very high risk with the worst mid-term prognosis belonging to the highest decile of 3C-HF score with the aim to assess predictors of survival in subjects with an expected probability of 1-year mortality near to 45%. Methods and resultsWe recruited 1777 consecutive chronic HF patients at 3 Italian Cardiology Units. Median age was 76±10years, 43% were female, and 32% had preserved ejection fraction. Subjects belonging to the highest decile of 3C-HF score were 246 (13.8% of total population). During a median follow-up of 21 [12–40] months, 110 of these patients (45%) survived and 136 (55%) died. The variables that contributed to survival prediction emerged by Cox regression multivariate analysis were the lower degree of renal dysfunction and higher body mass index. ConclusionsThe prognostic stratification of chronic HF patients allows in daily practice to select patients at different risk for death and identify prognosticators of survival in outliers at very high risk of death. The reasons why these patients outlive the matching part of subjects who expectedly die are related to the maintenance of a satisfactory renal function and body mass index.

Beta-Blockers in Children with Congenital Heart Disease Before a Corrective Procedure.

The prevalence of heart failure in patients with congenital heart disease, mainly due to large left to right shunts, is as high as 20%. Heart failure has a high impact on prognosis, growth and neurodevelopment. Prior to surgery or after palliative procedures children need a medical heart failure therapy. The traditional therapy with digoxin, diuretics and ACE-inhibitors is not supported by prospective randomized trials. Propranolol had a significant beneficial effect on the clinical heart failure score, neurohormonal activation, heart rate variability and cardiac remodeling in the prospective randomized trial CHF-Pro-Infant. Beta-blocker dosages depend on heart rate with a target between 100 and 110 bpm in infants and an average dose of 2mg/kg/day after a titration period of 2 to 3 weeks. Within the last 18 years after the first case the author treated only infants with severe heart failure and highly elevated Pro-BNP-levels (8879 pg/ml on average). However we never observed serious side effects due to worsening heart failure, severe bradycardia or pulmonary obstruction. Diuretics are given as low as necessary to prevent the activation of the renin-angiotensin-aldosterone system with its detrimental effect on cardiac remodeling.

Effects of grape seed proanthocyanidin extract on menopausal symptoms, body composition, and cardiovascular parameters in middle-aged women

This study aims to assess the effects of proanthocyanidin-a class of polyphenol antioxidants extracted from grape seeds-on menopausal symptoms, body composition, and cardiovascular parameters in middle-aged women. We conducted a randomized, double-blind, placebo-controlled study in 96 women aged 40 to 60 years who had at least one menopausal symptom. The study participants were randomized to receive grape seed extract tablets containing either low-dose (100 mg/d) or high-dose (200 mg/d) proanthocyanidin, or placebo, for 8 weeks. Their menopausal symptoms were evaluated using the Menopausal Health-Related Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, and Athens Insomnia Scale before and after 4 and 8 weeks of treatment. Body composition and cardiovascular parameters were also measured. A total of 91 women (95%) completed the study. Background characteristics, including age, menopause status, subjective symptom scores, body composition, and cardiovascular parameters, were similar among the groups. The following significant changes were observed during the course of the study: (1) physical symptom score, hot flash score, and (2) Athens Insomnia Scale score decreased in the high-dose group after 8 weeks of treatment; (3) Hospital Anxiety and Depression Scale Anxiety score and (4) systolic and diastolic blood pressure decreased in the low-dose and high-dose groups after 4 weeks; and, (5) lastly, muscle mass increased in the low-dose and high-dose groups after 8 weeks of treatment. Grape seed proanthocyanidin extract is effective in improving the physical and psychological symptoms of menopause while increasing muscle mass and reducing blood pressure in middle-aged women.

Physical and Psychological Symptom Profiling and Event-Free Survival in Adults With Moderate to Advanced Heart Failure

: Heart failure (HF) is a heterogeneous symptomatic disorder. The goal of this study was to identify and link common profiles of physical and psychological symptoms to 1-year event-free survival in adults with moderate to advanced HF. Multiple valid, reliable, and domain-specific measures were used to assess physical and psychological symptoms. Latent class mixture modeling was used to identify distinct symptom profiles. Associations between observed symptom profiles and 1-year event-free survival were quantified using Cox proportional hazards modeling. The mean age of the participants (n = 202) was 57 ± 13 years, 50% were men, and 60% had class III/IV HF. Three distinct profiles, mild (41.7%), moderate (30.2%), and severe (28.1%), that captured a gradient of both physical and psychological symptom burden were identified (P < .001 for all comparisons). Controlling for the Seattle HF Score, adults with the moderate symptom profile were 82% more likely (hazard ratio, 1.82; 95% confidence interval, 1.07-3.11; P = .028) and adults with the severe symptom profile were more than twice as likely (hazard ratio, 2.06; 95% confidence interval, 1.21-3.52; P = .001) to have a clinical event within 1 year than patients with the mild symptom profile. Profiling patterns among physical and psychological symptoms identifies HF patient subgroups with significantly worse 1-year event-free survival independent of prognostication based on objective clinical HF data.

Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

BackgroundWhether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy.DesignA multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure (AA group) and a control group using Climen® (Bayer Healthcare Company Limited, Guangzhou, China), a 28-day sequential hormone replacement therapy, in a 1:1 ratio. Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks, for a total of 28 sessions over 12 weeks. Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks, with both ears used alternately. The Climen® control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days. The total treatment period of the control group is three cycles. The post-treatment follow-up period will last 24 weeks. The primary outcome is the Menopause Rating Scale (MRS) assessed at baseline and 4, 12, 16, 24 and 36 weeks after randomization. The secondary outcomes are Menopause-Specific Quality of Life, average hot flash score during 24 hours, serum estradiol, follicle-stimulating hormone and luteinizing hormone level. The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12, 24 weeks after randomization.DiscussionThe results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.Trial registrationClinicalTrials.gov NCT01933204 (registered 9 August 2013)

NCCTG N10C2 (Alliance): A double-blind, placebo-controlled study of magnesium supplements to reduce menopausal hot flashes.

9508 Background: Hot flashes (HFs) are a common symptom in female breast cancer survivors that can negatively impact quality of life. Preliminary data suggest that magnesium may be an effective, low-cost treatment for HFs causing minimal side effects. Methods: A four-arm, double-blinded, placebo-controlled randomized trial was conducted. Postmenopausal women with a history of breast cancer and bothersome HFs were randomized into treatment groups of 800 mg or 1200 mg of magnesium oxide per day, or a corresponding placebo group in 2:2:(1:1) ratios. HF frequency and scores (number times severity) were measured using a validated HF diary. A one-week baseline period preceded initiation of study medication. The primary endpoint was the intra-patient difference in average hot flash score between baseline and at the end of the treatment period, comparing each magnesium arm to the combined placebo arms using a gate-keeping procedure. With a sample size of 80 patients per arm, there was 80% power to detect a differ...

Tamoxifen-associated hot flash severity is inversely correlated with endoxifen concentration and CYP3A4*22.

Tamoxifen use is often limited in some patients due to adverse effects including severe hot flash symptoms. Tamoxifen undergoes hepatic bioactivation by CYP2D6 and CYP3A4 to form the active metabolite endoxifen. It remains unclear whether the extent of attained endoxifen level or genetic polymorphisms in drug metabolizing enzymes is associated with the frequency and severity of hot flashes. We conducted a prospective study using self-reported surveys to assess tamoxifen side effects experienced during the week prior to clinic visits of 132 female breast cancer patients on tamoxifen therapy, and hot flash severity scores were tabulated. At the time of clinic visit, blood samples were obtained to determine tamoxifen and its metabolite levels and to determine CYP2D6 and CYP3A4 genotypes. The majority of participants (77%) experienced hot flashes, with 11% experiencing severe or very severe symptoms. We observed an inverse correlation between endoxifen concentration and hot flash severity score following adjustment for age, BMI, and menopausal status in patients with non-zero scores (p<0.001). Interestingly, CYP2D6 genotype was not significantly associated with hot flash scores in patients on no known inhibitory medications. However, CYP3A4*22 carriers were less likely to have hot flashes with an odds ratio of 8.87 (p<0.01) even when compared to a cohort with similar endoxifen levels. Our data demonstrate that patients with higher endoxifen levels tended to predict lower hot flash severity scores. Importantly, this is the first study to show CYP3A4*22 genotype as an independent predictor of hot flash severity during tamoxifen therapy.

Prevalence of risk factors for atrial fibrillation and stroke among 1210 patients with sleep disordered breathing

AimsThis study sought to identify the prevalence of risk factors for atrial fibrillation and stroke in a sleep apnea population. MethodsStudy participants included 1210 consecutive adults who were referred with suspicion of sleep apnea. Statistical analysis was used to determine the relationship between sleep apnea syndrome and risk factors for atrial fibrillation and stroke. ResultsAmong 1210 enrolled patients, 65.8% had severe sleep apnea (Apnea/hypopnea Index — AHI>30), 25.2% had mild to moderate sleep apnea (AHI 5 to 30), and 8.8% had no sleep apnea (AHI<5). At baseline, the mean apnea–hypopnea index in patients with sleep apnea syndrome was 35. Compared to patients with an AHI <5, those with an AHI >30 were older (47.3±11.4 vs. 52.74±12.4, p<0.001) and had a higher body mass index (BMI) (30.7±7.3 vs. 33.83±10.1, p<0.001), a higher prevalence of hypertension (38 vs. 16%, p<0.001), and a higher CHADS2 (congestive heart failure, hypertension, age, diabetes and prior stroke) score (0.59±0.8 vs. 0.28±0.64, p<0.001). ConclusionsPatients with severe sleep apnea have a higher prevalence of risk factors for atrial fibrillation and stroke when compared with subjects without sleep apnea.