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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522560-32-01
Acronym
Z-2025058
Enrollment
100
Registered
2025-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure in remission

Brief summary

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

Detailed description

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)

Interventions

DRUGLISINOPRIL EG 20 mg
DRUGcomprimé sécable
DRUGJardiance 10 mg film-coated tablets
DRUGBISOPROLOL EG 5 mg
DRUGSpironolactone 25mg Film-coated Tablets

Sponsors

Ziekenhuis Oost Limburg
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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)

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026