A Prospective, Randomized, Controlled Clinical Pilot Trial Investigating the Partial Down-titration of Guideline-directed Medical Therapy in Patients With Heart Failure in Remission. (TAPERED-HF)

NCT07513883 Phase 4 RECRUITING

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.

Details

Lead sponsor	Ziekenhuis Oost-Limburg
Phase	Phase 4
Status	RECRUITING
Enrolment	100
Start date	2026-03-16
Completion	2028-12

Conditions

• Heart Failure

Interventions

• Down-titration
• Continuation of guideline-directed heart failure therapy

Primary outcomes

• Time to first occurrence of recurrent adverse remodeling, significant NT-proBNP increase or all-cause mortality. — From enrollment to 2 year follow-up
  The primary outcome is a composite of (1) adverse remodeling, defined as an LVESVi increase of more than 20% from baseline using echocardiography, (2) a significant biomarker increase, defined as an NT-proBNP increase to more than 500 pg/mL, or (3) all-cause mortality.

Countries

Belgium