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

NCT06055504 · Consorcio Centro de Investigación Biomédica en Red (CIBER)
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About this study
Prospective, randomised, multicentre, open-label study to assess the non-inferiority of a personalised precision strategy for SCD prevention in patients with non-ischemic dilated cardiomyopathy with LVEF≤35% 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.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-06
Estimated completion: 2027-10-01
Last updated: 2024-02-28
Interventions
Other: Control StrategyOther: Personalized precision ICD implantation Strategy based in genetic findings and CMR results
Primary outcomes
  • Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events. (4 years)
Sponsor
Consorcio Centro de Investigación Biomédica en Red (CIBER) · other_gov
With: Instituto de Salud Carlos III
Contacts & investigators
ContactMaria de la Iglesia · contact · spanish-i@cibercv.es · +34911916749
ContactProjects Department (CIBER) · contact · proyectos@ciberisciii.es · +34 91 822 28 74
InvestigatorPablo García Pavía · principal_investigator, H.U. Puerta de Hierro, Majadahonda
InvestigatorAntoni Bayés Genís · principal_investigator, H.U. Germans Trias i Pujol
InvestigatorJavier Bermejo Thomas · principal_investigator, H.G.U. Gregorio Marañón
All locations (31)
H.C.U de Santiago de CompostelaRecruiting
Santiago de Compostela, A Coruña, Spain
H.U. de BellvitgeRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Parc TaulíNot Yet Recruiting
Sabadell, Barcelona, Spain
H.U. A CoruñaNot Yet Recruiting
A Coruña, La Coruña, Spain
H.U. Puerta de HierroRecruiting
Majadahonda, Madrid, Spain
H.U. Central de AsturiasRecruiting
Oviedo, Principality of Asturias, Spain
Hospital General Universitario Dr BalmisRecruiting
Alicante, Spain
H.U. de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
H. Clinic de BarcelonaNot Yet Recruiting
Barcelona, Spain
H.U. Germans Trias i PujolRecruiting
Barcelona, Spain
H.U. Vall d'HebronRecruiting
Barcelona, Spain
H.U. Josep TruetaRecruiting
Girona, Spain
H.U. Virgen de las NievesNot Yet Recruiting
Granada, Spain
Hospital Arnau de VilanovaRecruiting
Lleida, Spain
H.G.U. Gregorio MarañónRecruiting
Madrid, Spain
H.U. Ramón y CajalNot Yet Recruiting
Madrid, Spain
H. Clínico San CarlosRecruiting
Madrid, Spain
Hospital Universitario Fundación Jiménez DíazNot Yet Recruiting
Madrid, Spain
H.U. 12 de OctubreRecruiting
Madrid, Spain
H.U. Virgen de la VictoriaRecruiting
Málaga, Spain
H.C.U. Virgen de la ArrixacaRecruiting
Murcia, Spain
H.U. Son LlátzerRecruiting
Palma de Mallorca, Spain
Complejo Hospitalario de NavarraRecruiting
Pamplona, Spain
H.U de SalamancaRecruiting
Salamanca, Spain
H.U. Virgen del RocioRecruiting
Seville, Spain
Complejo Hospitalario Universitario de ToledoNot Yet Recruiting
Toledo, Spain
H.C.U de ValenciaNot Yet Recruiting
Valencia, Spain
H.U. Politécnico de la FeRecruiting
Valencia, Spain
Hospital General Universitario de ValenciaNot Yet Recruiting
Valencia, Spain
H.C.U de ValladolidRecruiting
Valladolid, Spain
H.U. Miguel ServetNot Yet Recruiting
Zaragoza, Spain
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1) · TrialPath