Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Recruiting · NCT06055504 · Interventional (participants receive a specific treatment) · Lead sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
View the official record on ClinicalTrials.gov →Interventions studied
Control StrategyPersonalized precision ICD implantation Strategy based in genetic findings and CMR results
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
31 locations listed.
- 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.C.U. Virgen de la Arrixaca - Murcia, Spain
- H.U. Virgen de la Victoria - Málaga, 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
- 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