NCT07851779RecruitingPhase 4
Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial. We aim to evaluate if the withdrawal of heart failure treatment is safe in patients with non-ischemic cardiomyopathy, negative genetic test, no evidence of late gadolinium enhancement on cardiac MRI, who have been super-responders to cardiac resynchronization therapy and remain free of heart failure events for at least 6 months after device implantation.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 14 Jan 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Diseases
- Heart failure
- NCT number
- NCT07851779
- EU CT number
- 2025-521780-12-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 64
- From 14 Jan 2026 to the primary completion date, 31 Jan 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was \>20%
Other illness
- Severe valvular heart disease
- History of sustained ventricular arrhythmia or treated by ICD
- Need to maintain beta-blocker therapy for other arrhythmias
- Hypertension not controlled with other medications
- Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines)
Lab values
- Family history of non-ischemic cardiomyopathy with LVEF \<50% in at least one first-degree relative
Who the study is looking for
- Diagnosis of non-ischemic cardiomyopathy
- LBBB already present at the time of first diagnosis of LV dysfunction
- Negative genetic test
- Cardiac MRI with no evidence of late gadolinium enhancement (LGE at RV insertion points is acceptable)
- Carrier of a resynchronization device (ICD or pacemaker, with LV epicardial pacing form a cardiac vein or left bundle area pacing), pacing percentage \>95% and paced QRS \<140 ms
- Device indication: LVEF ≤35% and LBBB with QRS \>150 ms
- LVEF ≥50% and normal indexed LV volumes on echocardiogram performed at least 6 months after CRT implantation
- No heart failure decompensations (no hospitalizations or urgent/day hospital visits) since CRT implantation
- No need for loop diuretic treatment
- NYHA class I or II
- NT-proBNP \<450 ng/L (or \<1000 ng/L in atrial fibrillation/flutter)
- On neurohormonal therapy with at least two drugs
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Trueta Coordinator of this site? Confirm its status | Girona | Spain | Recruiting |
| Hospital Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.