Sacubitril/Valsartan Versus Enalapril in Chronic Chagas Cardiomyopathy with Heart Failure: Baseline Characteristics of the PARACHUTE-HF Trial
Bibliographic record
Abstract
AIMS: The PARACHUTE-HF trial (NCT04023227) is evaluating the effect of sacubitril/valsartan compared with enalapril on a hierarchical composite of cardiovascular events (cardiovascular death, first heart failure hospitalization), and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in participants with heart failure and reduced ejection fraction (HFrEF) caused by chronic Chagas cardiomyopathy (CCC). We describe the baseline characteristics of participants in PARACHUTE-HF compared with prior HFrEF trials. METHODS AND RESULTS: PARACHUTE-HF, a multicentre, active-controlled, open-label trial, enrolled 922 participants with confirmed CCC, New York Heart Association (NYHA) functional class II-IV, and left ventricular ejection fraction (LVEF) ≤40%. Participants were randomized 1:1 to sacubitril/valsartan (97/103 mg bid) or enalapril (10 mg bid). Enrolled participants (mean age: 64.2 years, 42.0% women) had a baseline LVEF of 29.8% (NYHA class II: 61.7%; NHYA class III/IV: 38.2%). History included hypertension (40.5%), atrial fibrillation/flutter (32.5%), ventricular arrhythmia (24.7%) and stroke (12.5%). The majority of patients had cardiac conduction abnormalities and 46.0% had conventional pacemaker, cardiac resynchronization therapy or implantable cardioverter-defibrillator. Mean systolic blood pressure was 118 mmHg, and median NT-proBNP level was 1730 pg/ml. CONCLUSIONS: Baseline characteristics of this study highlight the unique clinical profile of patients with CCC-related HFrEF, including the high proportion of women affected, lower rates of comorbidities (hypertension/diabetes) and higher prevalence of stroke and pacemaker implantation when compared with other non-CCC-related HFrEF studies. These findings reinforce the need for dedicated heart failure treatments in this neglected subpopulation, particularly in Latin America where Chagas disease remains a significant public health issue.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".