Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
NCT ID: NCT06055504
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2023-09-06
2027-10-01
Brief Summary
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Detailed Description
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Randomization will be 1:1 and patients are allocated to either control strategy or intervention strategy.
In the control strategy group, patients will get an Implantable Cardioverter Defibrillator (ICD) implanted. 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 Dilated Cardiomyopathy DCM-causing pathogenic or likely pathogenic genetic variants or Late Gadolinium Enhancement (LGE) in Cardiac Magnetic Resonance (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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control Strategy
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Responsible Party
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Principal Investigators
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Pablo García Pavía
Role: PRINCIPAL_INVESTIGATOR
H.U. Puerta de Hierro, Majadahonda
Antoni Bayés Genís
Role: PRINCIPAL_INVESTIGATOR
H.U. Germans Trias i Pujol
Javier Bermejo Thomas
Role: PRINCIPAL_INVESTIGATOR
H.G.U. Gregorio Marañón
Javier Díez Martínez
Role: PRINCIPAL_INVESTIGATOR
University of Navarra
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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SPANISH-1
Identifier Type: -
Identifier Source: org_study_id
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