NCT06055504View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2027

Conditions
Non-ischemic Dilated Cardiomyopathy
Interventions
OTHER

Control Strategy

ICDs will be implanted in all patients according to current recommendations

OTHER

Personalized 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.

Trial Locations (31)

15006

NOT_YET_RECRUITING

H.U. A Coruña, A Coruña

15706

RECRUITING

H.C.U de Santiago de Compostela, Santiago de Compostela

17007

RECRUITING

H.U. Josep Trueta, Girona

18014

NOT_YET_RECRUITING

H.U. Virgen de las Nieves, Granada

25198

RECRUITING

Hospital Arnau de Vilanova, Lleida

28007

RECRUITING

H.G.U. Gregorio Marañón, Madrid

28034

NOT_YET_RECRUITING

H.U. Ramón y Cajal, Madrid

28040

RECRUITING

H. Clínico San Carlos, Madrid

NOT_YET_RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

RECRUITING

H.U. 12 de Octubre, Madrid

28222

RECRUITING

H.U. Puerta de Hierro, Majadahonda

29010

RECRUITING

H.U. Virgen de la Victoria, Málaga

30120

RECRUITING

H.C.U. Virgen de la Arrixaca, Murcia

31008

RECRUITING

Complejo Hospitalario de Navarra, Pamplona

33011

RECRUITING

H.U. Central de Asturias, Oviedo

37007

RECRUITING

H.U de Salamanca, Salamanca

41013

RECRUITING

H.U. Virgen del Rocio, Seville

45007

NOT_YET_RECRUITING

Complejo Hospitalario Universitario de Toledo, Toledo

46010

NOT_YET_RECRUITING

H.C.U de Valencia, Valencia

RECRUITING

H.U. Politécnico de la Fe, Valencia

46014

NOT_YET_RECRUITING

Hospital General Universitario de Valencia, Valencia

47003

RECRUITING

H.C.U de Valladolid, Valladolid

50009

NOT_YET_RECRUITING

H.U. Miguel Servet, Zaragoza

08907

RECRUITING

H.U. de Bellvitge, L'Hospitalet de Llobregat

08208

NOT_YET_RECRUITING

Hospital Parc Taulí, Sabadell

03010

RECRUITING

Hospital General Universitario Dr Balmis, Alicante

08025

RECRUITING

H.U. de la Santa Creu i Sant Pau, Barcelona

08036

NOT_YET_RECRUITING

H. Clinic de Barcelona, Barcelona

08916

RECRUITING

H.U. Germans Trias i Pujol, Barcelona

Unknown

RECRUITING

H.U. Vall d'Hebron, Barcelona

07198

RECRUITING

H.U. Son Llátzer, Palma de Mallorca

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

lead

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV