A trial investigating partial withdrawal of heart failure therapy in patients with heart failure in remission.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ziekenhuis Oost Limburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

1 Mar 2026 → ongoing

Decision date (initial)

2025-11-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To investigate the safety and feasibility of heart failure therapy down-titration versus therapy continuation in patients with heart failure in remission.

Secondary objectives 3

1. To assess differences in all-cause and heart failure-driven hospitalizations, and all-cause and cardiovascular deaths
2. To assess the proportion of patients needing therapy re-initiation.
3. To assess differences in change of natriuretic peptide concentrations, blood pressure, potassium, VO2max, quality of life, other echocardiographic markers of left ventricular function, UACR and eGFR

Conditions and MedDRA coding

Heart failure in remission

Regulatory references

Plan to share IPD

Yes

IPD plan description

Collected study data will be transcribed from the source documents into the eCRF by the PI or his study team. This will be done as soon as possible after the visit took place. All data that will be provided to the sponsor will be pseudonymized. Every subject receives a unique study number upon enrolment in the study. This unique number can only be linked to the participant through a subject identification file, containing at least the subject’s name, date of birth, hospital ID and unique study number. It is the responsibility of the PI to safeguard the subject identification file. The investigator and the participating site will treat all information and data relating to the study as confidential and will not disclose such information to any third parties or use such information for any purpose other than the performance of the study. The study will be conducted according to the legal and regulatory requirements.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adults aged ≥ 18 years
2. Heart failure in remission, defined as heart failure with an improved ejection fraction to an LVEF above 50%, with normalized LV volumes, an NT-proBNP ≤ 250 pg/mL, normal functional capacity, and clinical stability
3. Patients must receive at least 3 HF therapies (ACEi/ARB/ARNI, BB, and MRA or SGLT2i) for HF, consistent with international HF guidelines. Each therapy must have been titrated to the maximally tolerated dose, stable for at least 6 months prior to screening

Exclusion criteria 9

1. Albuminuric chronic kidney disease
2. Recent major cardiovascular events such as an acute coronary syndrome, CABG, stroke or TIA in the 90 days before screening
3. Uncontrolled hypertension
4. Atrial fibrillation or atrial flutter with a resting heart rate >110 beats per minute
5. Patients with a cardiac resynchronization therapy device who have < 98% biventricular pacing during screening
6. Any sustained ventricular arrythmias within 6 months prior to screening
7. Any untreated valvular heart disease of moderate or greater severity during screening.
8. Presence of any other disease with a life expectancy of < 2 years.
9. Pregnant or lactating women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 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
2. NT-proBNP increase to more than 500 pg/mL
3. All-cause mortality

Secondary endpoints 3

1. Time to first occurrence of all-cause mortality or all-cause hospitalizations
2. Change in KCCQ-12
3. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ziekenhuis Oost Limburg

Sponsor organisation

Ziekenhuis Oost Limburg

Address

Synaps Park 1

City

Genk

Postcode

3600

Country

Belgium

Scientific contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Wilfried Mullens

Public contact point

Organisation

Ziekenhuis Oost Limburg

Contact name

Wilfried Mullens

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications