A Pilot Feasibility Study in Recovered Heart Failure

• Status: Unknown status
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excellent long-term prognosis. Whether they need to remain on long-term medical therapy is not clear. The investigators will investigate the safety of therapy withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Criteria

Inclusion Criteria:

1. Have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details.

2. Be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist.

3. Have demonstrated evidence of left ventricular reverse remodelling following the initial diagnosis with subsequent improvement in ejection fraction to >50% and normalisation of left ventricular (LV) volumes.

4. Have no symptoms of heart failure (NYHA Class 1).

5. Low plasma NTproBNP.

Exclusion Criteria:

1. Uncontrolled hypertension.

2. More than moderate valvular disease.

3. Estimated glomerular filtration rate <30mls/min.

4. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.

5. Pregnancy.

6. Unstable angina.

7. Age <16 years