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

RecruitingNAAges 18 Years - anyAllConsorcio Centro de Investigación Biomédica en Re…
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In plain words

What the trial is, and whether it could suit you

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%

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
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What it tests

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

31 sites
H.C.U de Santiago de Compostela
Santiago de Compostela, Spain
H.U. de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Parc Taulí
Sabadell, Spain
H.U. A Coruña
A Coruña, Spain
H.U. Puerta de Hierro
Majadahonda, Spain
H.U. Central de Asturias
Oviedo, Spain
Hospital General Universitario Dr Balmis
Alicante, Spain
H.U. de la Santa Creu i Sant Pau
Barcelona, Spain

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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