Tests personalized defibrillator placement in people with non-ischemic dilated cardiomyopathy
Compares a gene and heart MRI guided defibrillator plan with standard care.
Plain-language title generated from the registry record
Registry title: Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Key facts
- Where
- A Coruña, Alicante, Barcelona, Girona, Granada, L'Hospitalet de Llobregat, Lleida, Madrid, Majadahonda, Málaga, Murcia, Oviedo, Palma de Mallorca, Pamplona, Sabadell, Salamanca, Santiago de Compostela, Seville, Toledo, Valencia, Valladolid, and Zaragoza, SpainSee the 31 sites
Where in Spain
- H.U. A CoruñaA Coruña, SpainNot yet recruiting
- Hospital General Universitario Dr. BalmisAlicante, SpainTaking people
- H Clinic de BarcelonaBarcelona, SpainNot yet recruiting
- H.U. de la Santa Creu i Sant PauBarcelona, SpainTaking people
- H.U. Germans Trias i PujolBarcelona, SpainTaking people
- H.U. Vall d'HebronBarcelona, SpainTaking people
- H.U. Josep TruetaGirona, SpainTaking people
- H.U. Virgen de las NievesGranada, SpainNot yet recruiting
- H.U. de BellvitgeL'Hospitalet de Llobregat, SpainTaking people
- Hospital Arnau de VilanovaLleida, SpainTaking people
- H. Clinico San CarlosMadrid, SpainTaking people
- H.G.U. Gregorio MarañónMadrid, SpainTaking people
- H.U. 12 de OctubreMadrid, SpainTaking people
- H.U. Ramón y CajalMadrid, SpainNot yet recruiting
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainNot yet recruiting
- H.U. Puerta de HierroMajadahonda, SpainTaking people
- H.U. Virgen de la VictoriaMálaga, SpainTaking people
- H.C.U. Virgen de la ArrixacaMurcia, SpainTaking people
- H.U. Central de AsturiasOviedo, SpainTaking people
- H.U. Son LlátzerPalma de Mallorca, SpainTaking people
- Complejo Hospitalario de NavarraPamplona, SpainTaking people
- Hospital Parc TauliSabadell, SpainNot yet recruiting
- H.U de SalamancaSalamanca, SpainTaking people
- H.C.U de Santiago de CompostelaSantiago de Compostela, SpainTaking people
- H.U. Virgen del RocíoSeville, SpainTaking people
- Complejo Hospitalario Universitario de ToledoToledo, SpainNot yet recruiting
- H.C.U de ValenciaValencia, SpainNot yet recruiting
- H.U. Politécnico de la FeValencia, SpainTaking people
- Hospital General Universitario de ValenciaValencia, SpainNot yet recruiting
- H.C.U de ValladolidValladolid, SpainTaking people
- H.U. Miguel ServetZaragoza, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Trial code
- NCT06055504
- Record updated
- 28 February 2024
- Original description
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%Read full original descriptionShow less
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
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%
Inclusion: 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: 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; History of recovered sudden death or sustained ventricular tachycardia; Waiting list for cardiac transplantation in emergency 0; Receiver of a solid organ transplant (lung, liver, heart or kidney); Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis; NYHA functional class IV.