Status:
COMPLETED
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chagas Disease
Heart Failure
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief 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 hiera...
Eligibility Criteria
Inclusion
- Key
- 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 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
- 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:
- 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
- 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:
- 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.
- 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)
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
918 Patients enrolled
Trial Details
Trial ID
NCT04023227
Start Date
December 10 2019
End Date
March 31 2025
Last Update
November 19 2025
Active Locations (79)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1221ADC
2
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425BEI
3
Novartis Investigative Site
Ramos Mejía, Buenos Aires, Argentina, B1704ETD
4
Novartis Investigative Site
San Martín, Buenos Aires, Argentina, 1604