Personalized defibrillator allocation for heart failure patients

Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)

This study is testing if a personalized method for deciding who gets a heart defibrillator can help people with heart failure just as well as the usual method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) (other gov)
• Drugs / interventions: chemotherapy
• Locations: 31 sites (Santiago de Compostela, A Coruña and 30 other locations)
• Trial ID: NCT06055504 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of non-ischemic dilated cardiomyopathy and an LVEF of 35% or less.

Not a fit: Patients with a history of coronary artery disease or other specific heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more tailored and effective prevention strategies for sudden cardiac death in heart failure patients.

How similar studies have performed: While personalized approaches in cardiology are gaining traction, this specific strategy is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Santiago de Compostela, A Coruña and 30 other locations

• 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)
• Hospital Parc Taulí — Sabadell, Barcelona, Spain (NOT_YET_RECRUITING)
• H.U. A Coruña — A Coruña, La Coruña, Spain (NOT_YET_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)
• H. Clinic de Barcelona — Barcelona, Spain (NOT_YET_RECRUITING)
• H.U. Germans Trias i Pujol — Barcelona, Spain (RECRUITING)
• H.U. Vall d'Hebron — Barcelona, Spain (RECRUITING)
• H.U. Josep Trueta — Girona, Spain (RECRUITING)
• H.U. Virgen de las Nieves — Granada, Spain (NOT_YET_RECRUITING)
• Hospital Arnau de Vilanova — Lleida, Spain (RECRUITING)
• H.G.U. Gregorio Marañón — Madrid, Spain (RECRUITING)
• H.U. Ramón y Cajal — Madrid, Spain (NOT_YET_RECRUITING)
• H. Clínico San Carlos — Madrid, Spain (RECRUITING)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (NOT_YET_RECRUITING)
• H.U. 12 de Octubre — Madrid, Spain (RECRUITING)
• H.U. Virgen de la Victoria — Málaga, Spain (RECRUITING)
• H.C.U. Virgen de la Arrixaca — Murcia, Spain (RECRUITING)
• H.U. Son Llátzer — Palma de Mallorca, Spain (RECRUITING)
• Complejo Hospitalario de Navarra — Pamplona, Spain (RECRUITING)
• H.U de Salamanca — Salamanca, Spain (RECRUITING)
• H.U. Virgen del Rocio — Seville, Spain (RECRUITING)
• Complejo Hospitalario Universitario de Toledo — Toledo, Spain (NOT_YET_RECRUITING)
• H.C.U de Valencia — Valencia, Spain (NOT_YET_RECRUITING)
• H.U. Politécnico de la Fe — Valencia, Spain (RECRUITING)
• Hospital General Universitario de Valencia — Valencia, Spain (NOT_YET_RECRUITING)
• H.C.U de Valladolid — Valladolid, Spain (RECRUITING)
• H.U. Miguel Servet — Zaragoza, Spain (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Pablo García Pavía — H.U. Puerta de Hierro, Majadahonda
• Study coordinator: Maria de la Iglesia

Conditions: Non-ischemic Dilated Cardiomyopathy