drugset / Trial / NCT07513883

The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.

NCT07513883

Phase 4 Recruiting 100 enrolled Ziekenhuis Oost-Limburg
RandomizedParallel-groupSingle-blindTreatment

Summary

Heart failure (HF) is a chronic condition that is characterized by a weakened and enlarged heart. It typically causes symptoms such as breathlessness and swelling of the legs, and it is a serious illness that shortens life expectancy. In recent years, new medicines have been developed that can improve heart function and help patients with HF live longer. HF patients with reduced heart function typically are recommended to take four different medicines for the rest of their lives. Some patients respond so well to treatment that their heart function and symptoms appear to recover; this is called HF in remission. While the four standard medicines have proven to increase lifespan in patients with heart failure with reduced heart function, it is not known whether they all need to be continued lifelong after recovery of the heart. Current guidelines recommend treating patients lifelong, yet this is based on limited scientific evidence. Lifelong therapy comes with disadvantages: it carries considerable costs for patients and health care systems, causes potential side effects, and makes it harder for patients to keep up with all their other medications. This study will test whether carefully reducing certain HF medicines is safe compared to continuing them. Patients with heart failure in remission will be randomly assigned to either: (1) continue all standard therapies, or (2) gradually reduce medicines to just two per day under close medical supervision. Patients will followed for two years to see whether their heart function remains stable. This will be measured by looking at echograms of the heart (echocardiograms), blood tests, and whether patients experience serious events such as hospitalizations or death. This study will investigate whether partial therapy discontinuation is safe and feasible.

Timeline

Start
2026-03-16
Primary completion
2028-09
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg
Subject Empagliflozin Small molecule 10 mg
Subject Eplerenone Unknown
Subject Spironolactone Small molecule
Subject sacubitril/valsartan Unknown
Background Bisoprolol Other / unclassified
Background Candesartan Unknown
Background Captopril Small molecule
Background Carvedilol Other / unclassified
Background Enalapril Other / unclassified
Background LISINOPRIL ANHYDROUS Small molecule
Background Losartan Other / unclassified
Background Nebivolol Other / unclassified
Background Ramipril Small molecule
Background Valsartan Small molecule
Background metroprolol Unknown
Background trandolapril Small molecule

Indications