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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
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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Trueta
Coordinator of this site? Confirm its status
GironaSpainRecruiting
Hospital Virgen de las Nieves
Coordinator of this site? Confirm its status
GranadaSpainRecruiting
Hospital Universitari de Bellvitge
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.