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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for Sudden Cardiac Death (SCD) prevention in patients with non-ischemic dilated cardiomyopathy with Left Ventricular Ejection Fraction (LVEF) ≤35%

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - expected to live at least 12 months. Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

OTHER

Control Strategy

ICDs will be implanted in all patients according to current recommendations

OTHER

Personalized precision ICD implantation Strategy based in genetic findings and CMR results

Patients allocated to the intervention strategy will receive an ICD according to genetic and CMR results. ICD implantation criteria in patients allocated to the personalised strategy group will be the presence of either a DCM-causing pathogenic or likely pathogenic genetic variants or LGE in CMR. Patients without DCM-associated genetic variants and without LGE on CMR will not receive standard treatment but an ICD will not be implanted on them.

Locations (20)

H.C.U de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
H.U. de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
H.U. A Coruña
A Coruña, La Coruña, Spain
H.U. Puerta de Hierro
Majadahonda, Madrid, Spain
H.U. Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario Dr Balmis
Alicante, Spain
H.U. de la Santa Creu i Sant Pau
Barcelona, Spain
H. Clinic de Barcelona
Barcelona, Spain
H.U. Germans Trias i Pujol
Barcelona, Spain
H.U. Vall d'Hebron
Barcelona, Spain
H.U. Josep Trueta
Girona, Spain
H.U. Virgen de las Nieves
Granada, Spain
Hospital Arnau de Vilanova
Lleida, Spain
H.G.U. Gregorio Marañón
Madrid, Spain
H.U. Ramón y Cajal
Madrid, Spain
H. Clínico San Carlos
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
H.U. 12 de Octubre
Madrid, Spain
H.U. Virgen de la Victoria
Málaga, Spain