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Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Summary
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%
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2023-09-06
Completion Date
2027-10-01
Last Updated
2024-02-28
Healthy Volunteers
No
Conditions
Interventions
Control Strategy
ICDs will be implanted in all patients according to current recommendations
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.
Locations (31)
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
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.U. Virgen de la Victoria
Málaga, Spain
H.C.U. Virgen de la Arrixaca
Murcia, 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