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Can a common heart drug help chagas patients? new trial results

NCT ID NCT04023227

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether sacubitril/valsartan (Entresto) works better than enalapril for people with heart failure caused by chronic Chagas disease. Over 900 adults with reduced heart function took part. The goal was to see if the drug could reduce heart-related deaths, hospitalizations, and improve a key heart stress marker (NT-proBNP).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacubitril/valsartan (Entresto)
What this could lead to
If it works, this could offer a better treatment option for people with heart failure caused by Chagas disease, potentially reducing hospitalizations and deaths.
What could go wrong
This is a phase 4 study, so the drug is already approved for other types of heart failure. However, it may not work as well in Chagas-related heart failure, and side effects like low blood pressure or kidney issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

922 people

The number who actually took part.

Started

Dec 2019

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Chagas cardiomyopathy Chagas disease heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chagas disease Heart failure

Contacts and locations

Locations

  • Novartis Investigative Site

    CABA, Buenos Aires, C1221ADC, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEI, Argentina

  • Novartis Investigative Site

    Ramos Mejía, Buenos Aires, B1704ETD, Argentina

  • Novartis Investigative Site

    San Martín, Buenos Aires, 1604, Argentina

  • Novartis Investigative Site

    Temperley, Buenos Aires, 1834, Argentina

  • Novartis Investigative Site

    Villa María, Córdoba Province, X5900JKA, Argentina

  • Novartis Investigative Site

    Salta, Salta Province, A4406BPF, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DIF, Argentina

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000IFL, Argentina

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000JCU, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1155 AHD, Argentina

  • Novartis Investigative Site

    Corrientes, W3400CDS, Argentina

  • Novartis Investigative Site

    Córdoba, 5000, Argentina

  • Novartis Investigative Site

    Córdoba, X5003DCE, Argentina

  • Novartis Investigative Site

    Córdoba, X5004BAL, Argentina

  • Novartis Investigative Site

    Córdoba, X5006CBI, Argentina

  • Novartis Investigative Site

    Formosa, P3600, Argentina

  • Novartis Investigative Site

    Formosa, P3634XAR, Argentina

  • Novartis Investigative Site

    Mendoza, M5500CHC, Argentina

  • Novartis Investigative Site

    Santa Fe, S3000EOZ, Argentina

  • Novartis Investigative Site

    Santa Fe, S3000FWO, Argentina

  • Novartis Investigative Site

    Santiago del Estero, G4200AQK, Argentina

  • Novartis Investigative Site

    Fortaleza, Ceará, 60125-025, Brazil

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430 370, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40050-410, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40110060, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40323-010, Brazil

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    Brasila, Federal District, 70673623, Brazil

  • Novartis Investigative Site

    Brasília, Federal District, 70390-700, Brazil

  • Novartis Investigative Site

    Brasília, Federal District, 70673-416, Brazil

  • Novartis Investigative Site

    Goiânia, Goiás, 74223-060, Brazil

  • Novartis Investigative Site

    Goiânia, Goiás, 74223-130, Brazil

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-020, Brazil

  • Novartis Investigative Site

    São Luís, Maranhão, 65020-070, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30140 062, Brazil

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-270, Brazil

  • Novartis Investigative Site

    Montes Claros, Minas Gerais, 39401-001, Brazil

  • Novartis Investigative Site

    Passos, Minas Gerais, 37904-020, Brazil

  • Novartis Investigative Site

    Uberaba, Minas Gerais, 38025-440, Brazil

  • Novartis Investigative Site

    Uberlândia, Minas Gerais, 38400 500, Brazil

  • Novartis Investigative Site

    Uberlândia, Minas Gerais, 38400-328, Brazil

  • Novartis Investigative Site

    Londrina, Paraná, 86038-440, Brazil

  • Novartis Investigative Site

    Belém, Pará, 66087-660, Brazil

  • Novartis Investigative Site

    Recife, Pernambuco, 50100-060, Brazil

  • Novartis Investigative Site

    Teresina, Piauí, 64001-380, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Novartis Investigative Site

    Botucatu, São Paulo, 3880-1001, Brazil

  • Novartis Investigative Site

    Bragança Paulista, São Paulo, 13183-091, Brazil

  • Novartis Investigative Site

    Campinas, São Paulo, 13020-431, Brazil

  • Novartis Investigative Site

    Campinas, São Paulo, 13060 080, Brazil

  • Novartis Investigative Site

    Campinas, São Paulo, 13060-904, Brazil

  • Novartis Investigative Site

    Indaiatuba, São Paulo, 13330-570, Brazil

  • Novartis Investigative Site

    Marília, São Paulo, 17515-000, Brazil

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14010-190, Brazil

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Novartis Investigative Site

    Santo André, São Paulo, 09080-001, Brazil

  • Novartis Investigative Site

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04012 909, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    Tatuí, São Paulo, 18270-170, Brazil

  • Novartis Investigative Site

    Votuporanga, São Paulo, 15500 003, Brazil

  • Novartis Investigative Site

    São Paulo, 05403-000, Brazil

  • Novartis Investigative Site

    São Paulo, 15015-210, Brazil

  • Novartis Investigative Site

    Bogota, Cundinamarca, 110121, Colombia

  • Novartis Investigative Site

    Santa Marta, Magdalena Department, 30360, Colombia

  • Novartis Investigative Site

    San Gil, Santander Department, 684031, Colombia

  • Novartis Investigative Site

    Bogota DC, 110111, Colombia

  • Novartis Investigative Site

    Florida Blanca, 681001, Colombia

  • Novartis Investigative Site

    Floridablanca, 681004, Colombia

  • Novartis Investigative Site

    Mérida, Yucatán, 97000, Mexico

  • Novartis Investigative Site

    Ciudad de, 14080, Mexico

  • Novartis Investigative Site

    Oaxaca City, 68000, Mexico

  • Novartis Investigative Site

    Xalapa, 91193, Mexico

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