Carvedilol as a single-drug therapy for Heart Failure with recovered ejection fraction: an open label randomized clinical trial

Phase 2

Recruiting

• Conditions: eft-side heart failure; I50

• Registration Number: RBR-75jm4cj
• Lead Sponsor: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 29 May 2023
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with previous diagnosis of reduced ejection fraction heart failure and documented ejection fraction equal or under 40% and actual ejection fraction equal or more than 50% and 10% greater than previous; Age equal or greater than 18 years old; absence of symptoms related to heart failure; Currently using carvedilol and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or neprilisin inhibitor with or without spironolactone; NT-proBNP under 250pg/mL; heart rate between 50 and 60 or maximum tolerated dose of carvedilol after runin fase or at least 50mg/day of carvedilol.

Exclusion Criteria

Ischemic cardiomyopathy; hypertensive cardiomyopathy: stage 3 hypertension as defined by the Brazilian Guideline of Hypertension or current blood pressure higher than 160x90mmHg; chagasic cardiomyopathy; valvar cardiomyopathy; infiltrative cardiomyopathy; chronic renal disease with creatinine clearance less than 30mL/min/1,73m²; formal indication for angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers such as diabetic patients with hypertension, diabetic nephropathy or another nephropathy with proteinuria.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate relapse of ventricular dysfunction in 6 months. We will consider a positive outcome if the patient fulfill one of the following criteria: reduction in left ventricular ejection fraction by more than 10% to less than 50% using transthoracic echocardiogram; an increase in left ventricular end diastolic volume indexed to body surface area by more than 10% and to higher the normal range using transthoracic echocardiogram; a 100% increase in N-terminal pro-brain natriuretic peptide to more than 400pg/mL; or clinical evidence of heart failure <br>