RecruitingNot ApplicableNCT06055504

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

Sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Enrollment

900 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

Non-ischemic Dilated Cardiomyopathy

Summary

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%

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to figure out which patients with a type of weakened heart muscle (non-ischemic dilated cardiomyopathy) actually benefit from having an implantable defibrillator (a device that prevents sudden cardiac death) versus those who may be able to avoid the device with optimized medications. **You may be eligible if...** - You have non-ischemic dilated cardiomyopathy (weakened heart not caused by blocked arteries) - Your heart's pumping function is 35% or less (low ejection fraction confirmed by cardiac MRI) - You are on maximum tolerated heart failure medications for at least 3 months - You are in NYHA functional class II or III (moderate heart failure symptoms) - You are 18 years or older with a life expectancy over 12 months **You may NOT be eligible if...** - You have coronary artery disease as the cause of your heart weakness - Your heart problem is due to a valve condition, congenital heart disease, alcohol abuse, or chemotherapy - You already have an implantable defibrillator Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERControl Strategy

ICDs will be implanted in all patients according to current recommendations

OTHERPersonalized 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(31)

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

H.C.U. Virgen de la Arrixaca

Murcia, Spain

H.U. Son Llátzer

Palma de Mallorca, Spain

Complejo Hospitalario de Navarra

Pamplona, Spain

H.U de Salamanca

Salamanca, Spain

H.U. Virgen del Rocio

Seville, Spain

Complejo Hospitalario Universitario de Toledo

Toledo, Spain

H.C.U de Valencia

Valencia, Spain

H.U. Politécnico de la Fe

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

H.C.U de Valladolid

Valladolid, Spain

H.U. Miguel Servet

Zaragoza, Spain

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