Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07513883

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

Led by Ziekenhuis Oost-Limburg · Updated on 2026-04-07

100

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent before randomization
  • Age 18 years or older
  • Previous diagnosis of heart failure with reduced ejection fraction (less than 40%)
  • Heart failure remission with improved ejection fraction (50% or higher) or described as normalized/recovered on heart imaging at least 6 months ago
  • Normal heart function measurements and low NT-proBNP levels at screening
  • Taking at least three heart failure medicines at maximally tolerated doses, stable for at least 6 months before screening
Not Eligible

You will not qualify if you...

  • Severe kidney disease with eGFR below 60 mL/min/1.73m2 and high urine albumin or need for dialysis or history of kidney transplant
  • Major cardiovascular events (heart attack, bypass surgery, stroke, or TIA) within 90 days before screening
  • Uncontrolled high blood pressure above 160/100 mmHg despite three medications
  • Atrial fibrillation or flutter with resting heart rate over 110 bpm at screening
  • Poor biventricular pacing (<98%) if treated with cardiac synchronization therapy
  • Other strong reasons to use SGLT2 inhibitors besides heart failure, like diabetes with cardiovascular disease or multiple risk factors
  • Sustained ventricular arrhythmias within 6 months before screening
  • Untreated moderate or severe valve heart disease at screening
  • Any other disease expected to limit life expectancy to less than 2 years
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ziekenhuis Oost-Limburg

Genk, Belgium, 3600

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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