Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
1 other identifier
interventional
900
1 country
31
Brief 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%
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2023
CompletedStudy Start
First participant enrolled
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedFebruary 28, 2024
February 1, 2024
2.1 years
April 24, 2023
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
4 years
Secondary Outcomes (6)
All-cause death
4 years
SCD
4 years
Hospitalisation for device-related complications
4 years
Non-fatal major arrhythmic events
4 years
cost-effectiveness
4 years
- +1 more secondary outcomes
Study Arms (2)
Control Strategy
OTHERPersonalized precision ICD implantation Strategy based in genetic findings and CMR results
EXPERIMENTALInterventions
ICDs will be implanted in all patients according to current recommendations
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Hypertrophic or infiltrative cardiomyopathy, active myocarditis or constrictive pericarditis.
- History of recovered sudden death or sustained ventricular tachycardia.
- NYHA functional class IV.
- Waiting list for cardiac transplantation in emergency 0.
- Receiver of a solid organ transplant (lung, liver, heart or kidney).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
H.C.U de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706, Spain
H.U. de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Parc Taulí
Sabadell, Barcelona, 08208, Spain
H.U. A Coruña
A Coruña, La Coruña, 15006, Spain
H.U. Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
H.U. Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario Dr Balmis
Alicante, 03010, Spain
H.U. de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
H. Clinic de Barcelona
Barcelona, 08036, Spain
H.U. Germans Trias i Pujol
Barcelona, 08916, Spain
H.U. Vall d'Hebron
Barcelona, Spain
H.U. Josep Trueta
Girona, 17007, Spain
H.U. Virgen de las Nieves
Granada, 18014, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
H.G.U. Gregorio Marañón
Madrid, 28007, Spain
H.U. Ramón y Cajal
Madrid, 28034, Spain
H. Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
H.U. 12 de Octubre
Madrid, 28041, Spain
H.U. Virgen de la Victoria
Málaga, 29010, Spain
H.C.U. Virgen de la Arrixaca
Murcia, 30120, Spain
H.U. Son Llátzer
Palma de Mallorca, 07198, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
H.U de Salamanca
Salamanca, 37007, Spain
H.U. Virgen del Rocio
Seville, 41013, Spain
Complejo Hospitalario Universitario de Toledo
Toledo, 45007, Spain
H.C.U de Valencia
Valencia, 46010, Spain
H.U. Politécnico de la Fe
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
H.C.U de Valladolid
Valladolid, 47003, Spain
H.U. Miguel Servet
Zaragoza, 50009, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo García Pavía
H.U. Puerta de Hierro, Majadahonda
- PRINCIPAL INVESTIGATOR
Antoni Bayés Genís
H.U. Germans Trias i Pujol
- PRINCIPAL INVESTIGATOR
Javier Bermejo Thomas
H.G.U. Gregorio Marañón
- PRINCIPAL INVESTIGATOR
Javier Díez Martínez
University of Navarra
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2023
First Posted
September 26, 2023
Study Start
September 6, 2023
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2027
Last Updated
February 28, 2024
Record last verified: 2024-02