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Taking people in SpainNo phase

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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have non-ischemic dilated cardiomyopathy and a weak heart pump (LVEF 35% or lower). It compares two ways of preventing sudden cardiac death.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Non-ischemic dilated cardiomyopathy already diagnosed; NYHA functional class II-III; LVEF ≤ 35% measured by cardiac MRI (CMR) as a study procedure; life expectancy over 12 months.
Earlier treatment
Must have had optimised medical treatment at the highest doses they can tolerate for at least 3 months before screening.

Main reasons for not taking part

  • Heart weakness caused by coronary artery disease
  • Heart weakness caused by congenital heart disease, valve disease, alcohol abuse or chemotherapy
  • Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis
  • Past recovered sudden death or sustained ventricular tachycardia
  • NYHA class IV, or on the emergency 0 heart transplant waiting list, or a solid organ transplant already received

Read by machine on 12 November 2026.

Where in Spain

  • H.U. A CoruñaA Coruña, SpainContact: Maria Generosa Crespo Leiro (principal investigator)Not yet recruiting
  • Hospital General Universitario Dr. BalmisAlicante, SpainContact: Juan Gabriel Martínez (principal investigator)Taking people
  • H Clinic de BarcelonaBarcelona, SpainContact: Josep Lluis Mont Girbau (principal investigator)Not yet recruiting
  • H.U. de la Santa Creu i Sant PauBarcelona, SpainContact: José M Guerra Ramos (principal investigator)Taking people
  • H.U. Germans Trias i PujolBarcelona, SpainContact: Antoni Bayés Genís (principal investigator)Taking people
  • H.U. Vall d'HebronBarcelona, SpainContact: Nuria Rivas Gándara (principal investigator)Taking people
  • H.U. Josep TruetaGirona, SpainContact: Ramón Brugada Terradellas (principal investigator)Taking people
  • H.U. Virgen de las NievesGranada, SpainContact: Juan Jiménez Jáimez (principal investigator)Not yet recruiting
  • H.U. de BellvitgeL'Hospitalet de Llobregat, SpainContact: José González Costello (principal investigator)Taking people
  • Hospital Arnau de VilanovaLleida, SpainContact: Jara Gayán Ordás (principal investigator)Taking people
  • H. Clinico San CarlosMadrid, SpainContact: Victoria Cañadas Godoy (principal investigator)Taking people
  • H.G.U. Gregorio MarañónMadrid, SpainContact: Javier Bermejo Thomas (principal investigator)Taking people
  • H.U. 12 de OctubreMadrid, SpainContact: Fernando Arribas Ynsaurriaga (principal investigator)Taking people
  • H.U. Ramón y CajalMadrid, SpainContact: Marta Jiménez-Blanco Bravo (principal investigator)Not yet recruiting
  • Hospital Universitario Fundación Jiménez DíazMadrid, SpainContact: Borja Ibáñez Cabeza (principal investigator)Not yet recruiting
  • H.U. Puerta de HierroMajadahonda, SpainContact: Pablo García Pavía (principal investigator)Taking people
  • H.U. Virgen de la VictoriaMálaga, SpainContact: José Manuel García-Pinilla (principal investigator)Taking people
  • H.C.U. Virgen de la ArrixacaMurcia, SpainContact: Domingo Pascual Figal (principal investigator)Taking people
  • H.U. Central de AsturiasOviedo, SpainContact: Rebeca Lorca Gutiérrez (principal investigator)Taking people
  • H.U. Son LlátzerPalma de Mallorca, SpainContact: Tomás Ripoll Vera (principal investigator)Taking people
  • Complejo Hospitalario de NavarraPamplona, SpainContact: Maria Teresa Basurte Elorz (principal investigator)Taking people
  • Hospital Parc TauliSabadell, SpainContact: Amadeo Marcelo Rizzo (principal investigator)Not yet recruiting
  • H.U de SalamancaSalamanca, SpainContact: Pedro Luis Sánchez Fernández (principal investigator)Taking people
  • H.C.U de Santiago de CompostelaSantiago de Compostela, SpainContact: J. Ramón González-Juanatey (principal investigator)Taking people
  • H.U. Virgen del RocíoSeville, SpainContact: Eduardo Arana Rueda (principal investigator)Taking people
  • Complejo Hospitalario Universitario de ToledoToledo, SpainContact: Miguel Ángel Arias Palomares (principal investigator)Not yet recruiting
  • H.C.U de ValenciaValencia, SpainContact: Julio Núñez Villota (principal investigator)Not yet recruiting
  • H.U. Politécnico de la FeValencia, SpainContact: Luis Martínez Dolz (principal investigator)Taking people
  • Hospital General Universitario de ValenciaValencia, SpainContact: Aurelio Quesada Dorador (principal investigator)Not yet recruiting
  • H.C.U de ValladolidValladolid, SpainContact: José Alberto San Román Calvar (principal investigator)Taking people
  • H.U. Miguel ServetZaragoza, SpainContact: Maria del Rosario Ortas Nadal (principal investigator)Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT06055504