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Clinical Trials in the EU / 2025-522560-32-01
Completed Phase IV

A prospective, randomized, controlled clinical pilot trial investigating the partial down-titration of guideline-directed medical therapy in patients with heart failure in remission

2025-522560-32-01 · tracked via the Priya Life Science EU tracker
Sponsor
Ziekenhuis Oost Limburg
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
10/11/2025
Enrollment target
100
Sites
Belgium

Condition studied

Heart failure in remission

Investigational medicinal product(s)

LISINOPRIL EG 20 mgcomprimé sécableJardiance 10 mg film-coated tabletsBISOPROLOL EG 5 mgcomprimé sécableSpironolactone 25mg Film-coated Tablets

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Left ventricular remodeling, measured in a core echocardiography laboratory as an increase in left ventricular end-systolic volume index of more than 20% from baseline, NT-proBNP increase to more than 500 pg/mL, All-cause mortality

Endpoint detail

Time to first occurrence of all-cause mortality or all-cause hospitalizations, Change in KCCQ-12, Proportion of patients requiring HF treatment re-initiation or escalation (i.e., (re-)initation of at least one guideline-directed medical therapy or starting a loop diuretic)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522560-32-01 on CTIS ↗ ← All trials in the EU