See if stopping heart failure meds is safe for super-responders with non-ischemic cardiomyopathy and CRT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective study is designed as a non-inferiority, randomized, single-blind trial where primary endpoint evaluators are blinded. Eligible participants are super-responders to CRT with non-ischemic cardiomyopathy, a negative genetic test, no late gadolinium enhancement on cardiac MRI (bar minor RV insertion LGE), and sustained CRT device function. Participants will be randomized to withdrawal of heart failure medications to determine if clinical status remains stable compared with continuing therapy. The trial seeks to establish whether stopping medications can be done safely in a highly selected group while maintaining heart failure control.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Family history of non-ischemic cardiomyopathy with LVEF \<50% in at least one first-degree relative
* 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
* CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was \>20%
* Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC/AHA guidelines)

Where it's running

• Hospital Universitari de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Trueta
  Girona, Spain Recruiting
• Hospital Virgen de las Nieves
  Granada, Spain Recruiting

Study contacts

• Study coordinator: Andrea Di Marco, MD, PhD
• Email: adimarco@bellvitgehospital.cat
• Phone: +34932607686

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Left bundle branch area pacing with multimodal guidance vs. conventional pacing for heart failure with complete left bundle branch block

  A multicenter trial tests whether using multimodal data to guide left bundle branch area pacing helps people with heart failure and complete left bundle branch block, compared with traditional biventricular pacing.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07814612

• MRI-guided risk-based pacing for heart failure with reduced ejection fraction

  This study tests whether left bundle branch pacing without a defibrillator works as well as traditional CRT with defibrillator in people with a specific heart failure and MRI-detected low risk of scar.

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• Conduction system pacing vs biventricular pacing for CRT

  This study tests whether pacing the heart’s conduction system (HIS or left bundle) during CRT works better than standard biventricular pacing for people with heart failure.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Aarhus and 4 other locations · NCT07492979

• Cardiac MRI for risk prediction in non-dilated left ventricular cardiomyopathy

  This retrospective study will test whether findings on cardiac MRI can help predict serious heart problems in people with non-dilated left ventricular cardiomyopathy.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07351838

• Registry and biobank of non-ischemic cardiomyopathy with linked heart imaging

  This project will collect clinical data, heart images, ECGs, and blood samples from people with non-ischemic cardiomyopathy and at-risk relatives to try to build and test tools that predict arrhythmia risk and guide family screening.

  Recruiting Montreal Heart Institute · Montreal, Quebec · NCT07110818

• Longitudinal Assessment of Cardiac MRI Microstructure in Patients and Healthy People

  This study tests advanced, non-contrast and extended clinical cardiac MRI techniques to see how heart tissue features differ between people with heart disease and healthy individuals.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07081711

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.