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NCT04023227

PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study was 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 chronic Chagas' cardiomyopathy (CCC).

Official title: A Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint, Phase 4 Study to Evaluate the Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With Chronic Chagas' Cardiomyopathy. The Study is Also Know as Prevention And Reduction of Adverse Outcomes in Chagasic Heart failUre Trial Evaluation (PARACHUTE-HF).

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

922

Start Date

2019-12-10

Completion Date

2025-03-31

Last Updated

2026-05-11

Healthy Volunteers

Conditions

Chagas Disease Heart Failure

Interventions

DRUG

Sacubitril/valsartan

Participants randomized to sacubitril/valsartan who were previously treated with angiotensin-converting enzyme inhibitors (ACEIs) had a 36-hour washout prior to receiving oral treatment with 50, 100, or 200 mg, film-coated tablets.

DRUG

Enalapril

Oral treatment with 5 or 10 mg tablets.

Key Inclusion Criteria: * Male or female ≥ 18 years of age * Diagnosis of NYHA Class II-IV HFrEF established by: 1. 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 2. NT-proBNP ≥ 600 pg/mL (or BNP ≥ 150 pg/mL) at Visit 1 OR 3. 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 two different serological tests for anti-Trypanosoma cruzi based on different principles or with different antigenic preparations, such as: enzyme-linked immunosorbent assay \[ELISA\], indirect immunofluorescence \[IFI\], indirect hemagglutination \[IHA\], western blot (WB), chemiluminescent immunoassay (CLIA). If documented history is not available, the tests may be performed during the screening Key Exclusion Criteria: * Patients with history of suspected or proven angioedema or unable to tolerate ACEIs, ARBs or ARNI (e.g., due to cough, hypotension, renal dysfunction, hyperkalemia) * Use of sacubitril/valsartan in the past 3 months * Patients requiring continuous intravenous inotropic therapy or with indication of advanced support intervention for HF: 1. already on list for a heart transplantation 2. 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 * Severe gastrointestinal form of chronic Chagas' disease (demonstrated megaesophagus and/or important megacolon, e.g.: with compromised oral intake or surgical indication). * 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: 1. Previous cardiac surgery 2. 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. 3. Untreated arrhythmia or serious conduction disease e.g., bradyarrhythmias, atrial fibrillation with rapid ventricular response, second or third degree atrioventricular block, etc. 4. Primary uncorrected valvar pathology like moderate to severe aortic stenosis, mitral stenosis and primary mitral regurgitation 5. 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. * Current confirmed COVID19 infection * Past COVID19 infection with persistent symptom burden suspected due to COVID19 (persistent symptoms may include, but are not limited to, continued cough, breathing difficulty, muscle/joint aches, and gastrointestinal symptoms from the time of COVID19 infection onward)

Locations (79)

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Ramos Mejía, Buenos Aires, Argentina

Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Novartis Investigative Site

Temperley, Buenos Aires, Argentina

Novartis Investigative Site

Villa María, Córdoba Province, Argentina

Novartis Investigative Site

Salta, Salta Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, San Miguel de Tucuman, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Formosa, Argentina

Novartis Investigative Site

Formosa, Argentina

Novartis Investigative Site

Mendoza, Argentina

Novartis Investigative Site

Santa Fe, Argentina

Novartis Investigative Site

Santa Fe, Argentina

Novartis Investigative Site

Santiago del Estero, Argentina

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

Fortaleza, Ceará, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Brasila, Federal District, Brazil

Novartis Investigative Site

Brasília, Federal District, Brazil

Novartis Investigative Site

Brasília, Federal District, Brazil

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

Goiânia, Goiás, Brazil

Novartis Investigative Site

São Luís, Maranhão, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil

Novartis Investigative Site

Montes Claros, Minas Gerais, Brazil

Novartis Investigative Site

Passos, Minas Gerais, Brazil

Novartis Investigative Site

Uberaba, Minas Gerais, Brazil

Novartis Investigative Site

Uberlândia, Minas Gerais, Brazil

Novartis Investigative Site

Uberlândia, Minas Gerais, Brazil

Novartis Investigative Site

Londrina, Paraná, Brazil

Novartis Investigative Site

Belém, Pará, Brazil

Novartis Investigative Site

Recife, Pernambuco, Brazil

Novartis Investigative Site

Teresina, Piauí, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Novartis Investigative Site

Ijuí, Rio Grande do Sul, Brazil

Novartis Investigative Site

Botucatu, São Paulo, Brazil

Novartis Investigative Site

Bragança Paulista, São Paulo, Brazil

Novartis Investigative Site

Campinas, São Paulo, Brazil

Novartis Investigative Site

Campinas, São Paulo, Brazil

Novartis Investigative Site

Campinas, São Paulo, Brazil

Novartis Investigative Site

Indaiatuba, São Paulo, Brazil

Novartis Investigative Site

Marília, São Paulo, Brazil

Novartis Investigative Site

Ribeirão Preto, São Paulo, Brazil

Novartis Investigative Site

Ribeirão Preto, São Paulo, Brazil

Novartis Investigative Site

Santo André, São Paulo, Brazil

Novartis Investigative Site

Sao Jose Rio Preto, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Tatuí, São Paulo, Brazil

Novartis Investigative Site

Votuporanga, São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Bogota, Cundinamarca, Colombia

Novartis Investigative Site

Santa Marta, Magdalena Department, Colombia

Novartis Investigative Site

San Gil, Santander Department, Colombia

Novartis Investigative Site

Bogota DC, Colombia

Novartis Investigative Site

Florida Blanca, Colombia

Novartis Investigative Site

Floridablanca, Colombia

Novartis Investigative Site

Mérida, Yucatán, Mexico

Novartis Investigative Site

Ciudad de, Mexico

Novartis Investigative Site

Oaxaca City, Mexico

Novartis Investigative Site

Xalapa, Mexico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (79)