Personalized defibrillator allocation for heart failure patients

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 study evaluates a personalized approach to implantable cardioverter defibrillator (ICD) allocation for patients with non-ischemic dilated cardiomyopathy and a left ventricular ejection fraction (LVEF) of 35% or less. Participants will be randomly assigned to either a control group receiving standard ICD implantation or an intervention group where ICD implantation is guided by genetic and cardiac magnetic resonance (CMR) findings. The goal is to determine if the personalized strategy is non-inferior in preventing sudden cardiac death compared to the standard approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years at the time of screening.
* Previously established diagnosis of Non-ischemic DCM
* Optimised medical treatment at maximum tolerated doses for at least 3 months prior to the screening date.
* NYHA functional class II-III.
* LVEF ≤ 35% documented by CMR as study procedure.
* Life expectancy greater than 12 months.

Exclusion Criteria:

* History of coronary artery disease justifying the presence of ventricular dysfunction, defined as: history of coronary revascularisation or presence of significant coronary stenosis (≥50% in left main or ≥70% in a major epicardial artery) on invasive or non-invasive coronary angiography (coronary CT)
* Left ventricular dysfunction attributed to congenital heart disease, valvular disease, alcohol abuse or chemotherapy.
* Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
* History of recovered sudden death or sustained ventricular tachycardia.
* NYHA functional class IV.
* Waiting list for cardiac transplantation in emergency 0.
* Receiver of a solid organ transplant (lung, liver, heart or kidney).

Where it's running

• H.C.U de Santiago de Compostela
  Santiago de Compostela, A Coruña, Spain Recruiting
• H.U. de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• H.U. Puerta de Hierro
  Majadahonda, Madrid, Spain Recruiting
• H.U. Central de Asturias
  Oviedo, Principality of Asturias, Spain Recruiting
• Hospital General Universitario Dr Balmis
  Alicante, Spain Recruiting
• H.U. de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Pablo García Pavía — H.U. Puerta de Hierro, Majadahonda
• Study coordinator: Maria de la Iglesia
• Email: spanish-i@cibercv.es
• Phone: +34911916749

Similar studies

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

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• Improving heart failure treatment for patients who don't respond to standard therapy

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  Recruiting Tomsk National Research Medical Center of the Russian Academy of Sciences · Tomsk · NCT05760924

• Using cardiac imaging to guide defibrillator implantation in heart failure patients

  This study is testing if getting a heart device called an ICD can help people with heart failure and heart damage live longer compared to just receiving standard heart care.

  Recruiting University of Luebeck · Lübeck, Schleswig-Holstein · NCT04558723

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.