Effect of Furosemide Withdraw in Stable Chronic Heart Failure Outpatients

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The ReBIC-1 trial was designed to evaluate the potential clinical risks and benefits of withdrawing furosemide use in stable, apparently euvolemic, chronic HF outpatients in a multicentric double-blinded randomized clinical trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Treatments: Furosemide

Criteria

The ReBIC-1 study will enroll HF outpatients that fulfill the following criteria:

1. age equal or greater than 18 year-old;

2. New York Heart Association functional class I or II;

3. Left Ventricular Ejection Fraction ≤ 45% by transthoracic two-dimensional echocardiography performed within 3 months before the screening visit;

4. no previous HF related hospitalization or visit to emergency room within 6 months before the screening visit;

5. treatment with a stable dose of furosemide (40 or 80 mg per day) for at least 6 months before the screening visit;

6. plasma potassium < 5 mg/dl within 3 months before the screening visit;

7. optimal HF treatment with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) and beta-blockers, unless contraindicated or not tolerated.

The ReBIC-1 study will exclude HF outpatients that fulfill the following criteria:

1. a clinical congestion score (CCS) > 5 points;

2. prior acute coronary syndrome, stroke or myocardial revascularization within 3 months before the screening visit;

3. any severe valve heart disease (aortic, mitral or tricuspid);

4. severe pulmonary disease (asthma, emphysema or fibrosis);

5. severe hepatic failure or cirrhosis;

6. end-stage acute or chronic renal disease (on hemodialysis);

7. malignancy on active treatment;

8. congenital heart disease;

9. participation on any other interventional clinical research;

10. inability to understand and sign informed consent.