Clinical Representativeness of the PARADIGM-HF Study in an Outpatient Cohort of Patients with Heart Failure, Including Chagas Disease, Treated According to Guideline-directed Medical Therapy: Prospective Study, in a Single Center in Brazil

Abstract

Background: In the PARADIGM-HF trial there was a 20% reduction in hospitalization and cardiovascular mortality in patients with heart failure (HF) and treated according to guideline-directed medical therapy. Eligibility for the use of sacubitril/valsartan in the real world has varied between 12% and 76%. There are no studies on the national scene on this eligibility.
 Aims: To investigate the clinical eligibility of the PARADIGM-HF trial in patients with HF in the outpatient clinic of a university institution, which also includes Chagas disease, and to compare the profile of the two populations.
 Study Design: This is a single center, prospective, observational study.
 Place and Duration of Study: Department of Internal Medicine, Faculty of Medicine, Hospital das Clínicas, Federal University of Minas Gerais, Brazil, duration 6 consecutive months.
 Methods and Results: We included 136 consecutive outpatients with HF, 53 women, and mean age of 54.2 years, underwent clinical and laboratory evaluation. The main etiologies of HF were ischemic, Chagas disease and idiopathic. The means of baseline variables were 117.2 mmHg for systolic blood pressure, 78.4 bpm for heart rate, 1.8 for dyspnea functional class, 0.39 for ejection fraction (EF) and 74.2 mL/min for creatinine clearance. The exclusion criteria considered in the PARADIGM-HF trial and present in this study were systolic blood pressure less than 95 mmHg in 15.4% and creatinine clearance less than 30 mL/min in 5.1% of patients. 22.1% had mid-range EF and 55.9% had reduced EF. Comparing this cohort of patients with the population of the PARADIGM-HF trial, age, systolic blood pressure, proportion of male patients, ischemic etiology, hypertension, patients with atrial fibrillation, use of angiotensin-converting enzyme inhibitor, furosemide and beta-blocker were lower in this study (p ≤ 0.01, chi-square and Student's t tests). The proportion of diabetic patients, use of angiotensin receptor blocker, aldosterone antagonist and digoxin were similar between groups as well as proportion of patients with cardiac resynchronization therapy.
 Conclusions: Up to 44% of patients in this study did not meet the main randomized trial criteria. Chagas disease was one of the main etiologies. Furthermore, systolic blood pressure, proportion of hypertensive patients was lower, which may have influenced the underutilization of some medications.