Change In New York Heart Association Class Research Articles

Comparison of losartan and captopril on heart failure–related outcomes and symptoms from the losartan heart failure survival study (ELITE II)

Blockade of the renin-angiotensin system with angiotensin-converting enzyme inhibitors improves outcomes and symptoms in patients with heart failure (HF). We compared effects of losartan to captopril on mortality, morbidity, and functional status for patients in the ELITE II study. A total of 3152 patients, aged 60 years or older, with New York Heart Association (NYHA) classes II to IV HF and ejection fraction < or = 40% were assigned to receive losartan 50 mg once daily or captopril 50 mg 3 times daily. Outcome measures included all-cause and HF-related mortality, hospitalizations, and discontinuations; change in NYHA class; and quality of life (QoL). HF-related outcomes were not significantly different between therapies. Similar improvements from baseline (P < .01) in NYHA class were observed within both treatment groups. Among 1856 QoL participants, 1343 patients survived at least 1 year; the QoL for 1-year survivors improved in both treatment groups (P < .001 vs baseline) and did not differ between groups. In ELITE II, the effects of losartan on HF-related outcomes, NYHA class, and QoL were not superior to those of captopril. Although angiotensin-converting enzyme inhibitors remain the treatment of choice for patients with HF, the similarity of the findings in the present analysis supports a role for angiotensin-receptor antagonists in this patient population.

Broad Modulation of Tissue Responses (Immune Activation) by Celacade May Favorably Influence Pathologic Processes Associated with Heart Failure Progression

Immune activation and inflammation contribute to the progression of chronic heart failure (CHF), but therapeutic approaches directed against these processes have been largely unsuccessful. This clinical study evaluated a novel, nonpharmacologic immune modulation therapy, shown experimentally to reduce inflammatory and increase anti-inflammatory cytokines. A total of 75 patients with New York Heart Association (NYHA) functional class III or IV CHF were randomized to receive either Celacade (immune modulation therapy) or placebo (n = 38 and n = 37, respectively) in a double-blind trial for 6 months, during which standard therapy for CHF was maintained. Patients were evaluated using the 6-minute walk test, changes in NYHA class, cardiac function, and quality-of-life assessments, and were observed for the occurrence of death and hospitalization. There was no between-treatment difference in the 6-minute walk test results, but 15 Celacade-treated patients (compared with 9 placebo-treated patients) improved NYHA classification by > or = 1 class (p = 0.140). Kaplan-Meier survival analysis showed that Celacade significantly reduced the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a clinical composite score demonstrated a significant between-group difference (p = 0.006). There was no difference in left ventricular ejection fraction between groups, but there was a trend toward improved quality of life favoring the Celacade-treated group (p = 0.110). These preliminary findings are consistent with the hypothesis that immune activation is important in the pathogenesis of CHF, and they establish the basis for a phase 3 trial to define the benefit of Celacade in CHF.

Correlation between Right Ventricular Indices and Clinical Improvement in Epoprostenol Treated Pulmonary Hypertension Patients

The aim of this study was to evaluate which parameter of right ventricular (RV) echocardiographic best mirrors the clinical status of patients with pulmonary arterial hypertension. Patients with pulmonary arterial hypertension on epoprostenol therapy were identified via hospital registry. Twenty patients, (16 females, 4 males) were included in the study, 9 with primary pulmonary hypertension and 11 with other diseases. Echocardiograms before therapy and at 22.7 (+/-9.3) months into therapy were compared. The right ventricular myocardial performance index (RVMPI) was measured as the sum of the isometric contraction time and the isometric relaxation time divided by right ventricular ejection time. Other measures included peak tricuspid regurgitation jet velocity (TRV), pulmonary artery systolic pressure (PASP), pulmonary valve velocity time integral (PVVTI), PASP/PVVTI (as an index of total pulmonary resistance) and symptoms by New York Heart Association (NYHA) functional class. Echo parameters of right ventricular function were analyzed in patients, before and during therapy. There was significant improvement of NYHA class in patients following epoprostenol therapy (P < 0.0001). Peak tricuspid regurgitant jet velocity (pre 4.2 +/- 0.6 m/sec, post 3.8 +/- 0.7 m/sec, P = 0.02) and PASP/PVVTI (pre 6.7 +/- 3.3 mmHg/m per second, post 4.8 +/- 2.2 mmHg/m per second, P < 0.0001) were significantly improved during treatment. RVMPI did not improve (pre 0.6 +/- 0.3, post 0.6 +/- 0.3, P = 0.54). Changes in NYHA class did not correlate with changes in RVMPI (P = 0.33) or changes in PASP/PVVTI (P = 0.58). Despite significant improvements in TRV, PASP/PVVTI, and NYHA class, there was no significant change in RVMPI on epoprostenol therapy. Changes in right ventricular indices were not correlated with changes in NYHA class.

Effect of candesartan on New York Heart Association functional classResults of the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) programme

To evaluate the effect of the angiotensin receptor blocker candesartan on New York Heart Association (NYHA) functional class in a broad spectrum of patients with chronic heart failure (CHF). Patients in the CHARM Programme with symptomatic CHF were randomized to placebo (n=3796) or candesartan (n=3803) and followed for a median of 38 months. NYHA class was assessed at baseline, at two weekly intervals during dose titration and 4 monthly thereafter. Patients were classified as "better", "unchanged" or "worse" at the end of the study compared to baseline. Both a simple "last visit carried forward" (LVCF) analysis and "worst rank carried forward" (WRCF) analysis (where patients who died were allocated NYHA class V) were used. In the LVCF analysis, compared to placebo, more candesartan patients improved (35.4% versus 32.5%) and fewer worsened (9.0% versus 10.3%) in NYHA class (p=0.003). The WRCF analysis also showed a better overall change in NYHA class with candesartan compared to placebo. There was no heterogeneity in the response to candesartan between the CHARM component trials. Candesartan improves NYHA functional class to a similar extent to other proven treatments for CHF when added to these other treatments.

A controlled trial of including symptom data in computer-based care suggestions for managing patients with chronic heart failure

Background Heart failure is common and associated with considerable morbidity and cost, yet physician adherence to treatment guidelines is suboptimal. We conducted a randomized controlled study to determine if adding symptom information to evidence-based, computer-generated care suggestions would affect treatment decisions among primary care physicians caring for outpatients with heart failure at two Veterans Affairs medical centers. Methods Physicians were randomly assigned to receive either care suggestions generated with electronic medical record data and symptom data obtained from questionnaires mailed to patients within 2 weeks of scheduled outpatient visits (intervention group) or suggestions generated with electronic medical record data alone (control group). Patients had to have a diagnosis of heart failure and objective evidence of left ventricular systolic dysfunction. We assessed physician adherence to heart failure guidelines, as well as patients' New York Heart Association (NYHA) class, quality of life, satisfaction with care, hospitalizations, and outpatient visits, at 6 and 12 months after enrollment. Results Patients in the intervention (n = 355) and control (n = 365) groups were similar at baseline. At 12 months, there were no significant differences in adherence to care suggestions between physicians in the intervention and control groups (33% vs. 30%, P = 0.4). There were also no significant changes in NYHA class ( P = 0.1) and quality-of-life measures ( P >0.1), as well as no differences in the number of outpatient visits between intervention and control patients (6.7 vs. 7.1 visits, P = 0.48). Intervention patients were more satisfied with their physicians ( P = 0.02) and primary care visit ( P = 0.02), but had more all-cause hospitalizations at 6 months (1.5 vs. 0.7 hospitalizations, P = 0.0002) and 12 months (2.3 vs. 1.7 hospitalizations, P = 0.05). Conclusion Adding symptom information to computer-generated care suggestions for patients with heart failure did not affect physician treatment decisions or improve patient outcomes.

Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias

ObjectivesThis study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy (CRT) when combined with an implantable cardioverter defibrillator (ICD). BackgroundLong-term outcome of CRT was measured in patients with symptomatic heart failure (HF), intraventricular conduction delay, and malignant ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]) requiring therapy from an ICD. MethodsPatients (n = 490) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT (n = 245) or control (no CRT, n = 245) for up to six months. The primary end point was progression of HF, defined as all-cause mortality, hospitalization for HF, and VT/VF requiring device intervention. Secondary end points included peak oxygen consumption (VO2), 6-min walk (6 MW), New York Heart Association (NYHA) class, quality of life (QOL), and echocardiographic analysis. ResultsA 15% reduction in HF progression was observed, but this was statistically insignificant (p = 0.35). The CRT, however, significantly improved peak VO2(0.8 ml/kg/min vs. 0.0 ml/kg/min, p = 0.030) and 6 MW (35 m vs. 15 m, p = 0.043). Changes in NYHA class (p = 0.10) and QOL (p = 0.40) were not statistically significant. The CRT demonstrated significant reductions in ventricular dimensions (left ventricular internal diameter in diastole = −3.4 mm vs. −0.3 mm, p < 0.001 and left ventricular internal diameter in systole = −4.0 mm vs. −0.7 mm, p < 0.001) and improvement in left ventricular ejection fraction (5.1% vs. 2.8%, p = 0.020). A subgroup of patients with advanced HF (NYHA class III/IV) consistently demonstrated improvement across all functional status end points. ConclusionsThe CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay.

Delapril versus enalapril in patients with congestive heart failure

This 12-month, multicenter, randomized, parallel-group study compared the effects of delapril with enalapril in 179 patients with congestive heart failure, New York Heart Association (NYHA) classes II and III. The initial doses of delapril (7.5 mg twice daily [BID]) and enalapril (2.5 mg BID) could be doubled every other week, to a maximum of 30 mg BID and 10 mg BID, respectively. Efficacy was assessed based on the changes in NYHA class, echocardiographic variables, cardiothoracic ratio, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular systolic wall stress, ejection fraction results of the exercise test, and patient's opinion of clinical status using a 4-point scale. Safety was assessed by monitoring the adverse events, laboratory tests, blood pressure, and electrocardiography. A significant decrease in left ventricular end-systolic volume was observed in the delapril group after 3 ( P < 0.01), 6 ( P < 0.01), and 12 ( P < 0.05) months; no significant changes were seen in the enalapril group in this period. Both treatments significantly reduced wall stress and improved ejection fraction at 3 (delapril, P < 0.01; enalapril, P < 0.05), 6 ( P < 0.01 for both groups), and 12 (delapril, P < 0.01; enalapril, P < 0.05) months, and significantly improved ejection fraction ( P < 0.01). None of the between-group differences were significant. Both treatments produced a significant improvement compared with baseline in the duration of exercise, workload, and work performed at 3 and 12 months. There was a significant difference between treatments in workload at 3 months ( P < 0.05) in favor of delapril. Heart rate was significantly reduced at day 30 ( P < 0.01), day 45 ( P < 0.05), and month 6 ( P < 0.05) only in the delapril group. The frequency and type of adverse events were similar in the 2 groups. One-year mortality was 5.7% in the delapril group and 6.6% in the enalapril group. These results suggest that treatment with delapril, an angiotensin-converting enzyme (ACE) inhibitor with affinity and selectivity for the C-site of the left ventricle and coronary arteries, may have some modest benefits when compared with a nonselective ACE inhibitor such as enalapril. However, more study is needed in larger patient populations.

A Pharmacoeconomic assessment of torsemide and furosemide in the treatment of patients with congestive heart failure

The management of patients with congestive heart failure (CHF) can place a significant economic burden on managed care organizations, leading providers to seek treatments that are cost-effective. Diuretics play a significant role in the treatment of edema associated with CHF. We evaluated the use of 2 loop diuretics, torsemide and furosemide, in patients with CHF in a managed care setting. This prospective study compared clinical, economic, and qualityof-life outcomes in 240 patients randomized to the 2 drugs. Patients with New York Heart Association (NYHA) class II or class III CHF requiring loop diuretic treatment, either alone or in conjunction with other therapy, were eligible. Patients were told about the study during an office visit, and those with an interest in participating and who met the eligibility criteria were given further information and the opportunity to participate. After investigators obtained informed consent, patients were enrolled, randomized to either treatment, and followed for 6 months. Outcomes included CHF/cardiovascular (CV)-related medical costs, change in NYHA class, change in sodium retention score, hospitalizations, physician visits, medication use, adverse events, and change in quality of life. A total of 103 patients were randomized to torsemide, and 137 patients were randomized to furosemide. Except for body weight, patient demographic characteristics did not differ between groups at baseline; patients in the torsemide group were significantly heavier ( P = 0.004). The results showed that mean total CHF/CV-related medical costs did not differ between groups (torsemide, $1520.07; furosemide, $1503.26; P = 0.975), despite higher mean drug-acquisition costs for torsemide patients ($121.01 vs $42.95; P < 0.0001). Mean costs were similar for CHF/CV-related hospitalizations (torsemide, $845.84; furosemide, $893.33; P = 0.918) and CHF-related physician visits (torsemide, $138.80; furosemide, $164.09; P = 0.288). Quality of life was significantly better for patients in the torsemide group at month 4 ( P = 0.017), but not at month 2 ( P = 0.059) or month 6 ( P = 0.269). The number of adverse events did not differ significantly between groups (torsemide, 221; furosemide, 287; P= 0.916). The results of this study appear to indicate that in a representative cross-section of managed care patients, those who received torsemide, despite higher drug-acquisition costs, had similar CHF/CV-related management costs compared with furosemide recipients.

Clinical and haemodynamic effects of diazoxide in primary pulmonary hypertension.

Diazoxide was injected into the pulmonary artery in nine patients with primary pulmonary hypertension. There was no significant change in pulmonary artery pressure, which fell by more than 10 mmHg in only two patients. The pulmonary blood flow increased in all patients as a result of a fall in pulmonary vascular resistance (by 4 to 17 units). Systematic vasuclar resistance also fell as expected in all patients. Oral diazoxide was given to seven patients, two of whom showed sustained clinical improvement while remaining on treatment (400 to 600 mg daily). Five patients were unable to tolerate the drug, because of nausea and sickness (two), peripheral oedema requiring large doses of diuretics (four), diabetes (three), and postural hypotension (one). Hirsutes was troublesome in the two patients remaining on treatment. Diazoxide may be useful in the management of some patients with primary pulmonary hypertension, but its use is limited by the frequency of side effects. Our results suggest that examination of othe potent vasodilators may be worth while.