Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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%
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
H.U. A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital General Universitario Dr Balmis
RECRUITING
Alicante
H. Clinic de Barcelona
NOT_YET_RECRUITING
Barcelona
H.U. de la Santa Creu i Sant Pau
RECRUITING
Barcelona
H.U. Germans Trias i Pujol
RECRUITING
Barcelona
H.U. Vall d'Hebron
RECRUITING
Barcelona
H.U. Josep Trueta
RECRUITING
Girona
H.U. Virgen de las Nieves
NOT_YET_RECRUITING
Granada
H.U. de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Arnau de Vilanova
RECRUITING
Lleida
H. Clínico San Carlos
RECRUITING
Madrid
H.G.U. Gregorio Marañón
RECRUITING
Madrid
H.U. 12 de Octubre
RECRUITING
Madrid
H.U. Ramón y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
H.U. Puerta de Hierro
RECRUITING
Majadahonda
H.U. Virgen de la Victoria
RECRUITING
Málaga
H.C.U. Virgen de la Arrixaca
RECRUITING
Murcia
H.U. Central de Asturias
RECRUITING
Oviedo
H.U. Son Llátzer
RECRUITING
Palma De Mallorca
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Hospital Parc Taulí
NOT_YET_RECRUITING
Sabadell
H.U de Salamanca
RECRUITING
Salamanca
H.C.U de Santiago de Compostela
RECRUITING
Santiago De Compostela
H.U. Virgen del Rocio
RECRUITING
Seville
Complejo Hospitalario Universitario de Toledo
NOT_YET_RECRUITING
Toledo
H.C.U de Valencia
NOT_YET_RECRUITING
Valencia
H.U. Politécnico de la Fe
RECRUITING
Valencia
Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
H.C.U de Valladolid
RECRUITING
Valladolid
H.U. Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Contact Information
Primary
Maria de la Iglesia
spanish-i@cibercv.es
+34911916749
Backup
Projects Department (CIBER)
proyectos@ciberisciii.es
+34 91 822 28 74
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 900
Treatments
Other: Control Strategy
Experimental: Personalized precision ICD implantation Strategy based in genetic findings and CMR results
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Salud Carlos III
Leads: Consorcio Centro de Investigación Biomédica en Red (CIBER)