Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC (PARACHUTE-HF)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2022
  • participants needed
    900
  • sponsor
    Novartis Pharmaceuticals
Updated on 1 March 2022
ejection fraction
heart failure
nt-probnp
nesiritide
b-type natriuretic peptide
natriuretic peptide
MRI
enalapril
valsartan
serology test
enzyme-linked immunosorbent assay
ventricular angiography

Summary

The purpose of this study is to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of cardiovascular (CV) events (i.e. CV death or the occurrence of first HF hospitalization) and causing a greater reduction in n terminal prohormone of brain natriuretic peptide (NT-proBNP, at Week 12 from Baseline) in participants with HF with reduced ejection fraction (HFrEF) caused by CCC.

Details
Condition Chagas Disease, Heart Failure
Treatment Enalapril, sacubitril/valsartan
Clinical Study IdentifierNCT04023227
SponsorNovartis Pharmaceuticals
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female ≥ 18 years of age
Diagnosis of NYHA Class II-IV HFrEF established by
LVEF ≤ 40% within 12 months prior to Visit 1 made by any local measurement using echocardiography, multiple gated acquisition scan (MUGA), computerized tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography, provided no subsequent measurement above 40% AND
NT-proBNP ≥ 600 pg/mL (or BNP ≥ 150 pg/mL) at Visit 1 OR
NT-proBNP ≥ 400 pg/mL (or BNP ≥ 100 pg/mL) at Visit 1 and a hospitalization for HF within the last 12 months
Chagas' disease diagnosis confirmed by at least 2 different serological tests for
anti-Trypanosoma cruzi (enzyme-linked immunosorbent assay [ELISA], indirect
immunofluorescence [IFI], and indirect hemagglutination [IHA]). If documented
history is not available, the tests may be performed during the screening

Exclusion Criteria

Patients with history of suspected or proven angioedema or unable to tolerate ACEIs or ARBs (e.g., due to cough, hypotension, renal dysfunction, hyperkalemia)
Previous use of sacubitril/valsartan
Patients requiring continuous intravenous inotropic therapy or with indication of advanced support intervention for HF
already on list for a heart transplantation
with current indication of left ventricular assist device, or cardiac resynchronization therapy (CRT)
Systemic systolic blood pressure lower than 95 mmHg or symptomatic hypotension
Serum potassium > 5.2 mmol/L
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 of body surface area
Known gastrointestinal form of chronic Chagas' disease: demonstrated megaesophagus; important megacolon
Clinical conditions or systemic diseases limiting proper patient participation
Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
Presence of other cardiac conditions
Previous cardiac surgery
Heart failure where, in the Investigator's judgement, there is a possible alternative primary etiology e.g., due to coronary artery disease, valve disease, congenital heart disease or other causes
Untreated arrhythmia or serious conduction disease e.g., bradyarrhythmias, atrial fibrillation with rapid ventricular response, second or third degree atrioventricular block, etc
Primary uncorrected valvar pathology like moderate to severe aortic stenosis, mitral stenosis and primary mitral regurgitation
Planned organ transplantation (or in listing for transplantation), planned cardiac or other major surgery (including ventricular assist device implantation)
History of malignancy of any organ system within the past 5 years
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