Clinical trial NCT06055504: Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Official title: Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-ischemic Dilated Cardiomyopathy
Lead sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Salud Carlos III
First posted: 2023-09-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%

Detailed description: 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).

Primary outcomes:
measure: Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.
timeFrame: 4 years
Secondary outcomes:
measure: All-cause death
timeFrame: 4 years
measure: SCD
timeFrame: 4 years
measure: Hospitalisation for device-related complications
timeFrame: 4 years
measure: Non-fatal major arrhythmic events
timeFrame: 4 years
measure: cost-effectiveness
timeFrame: 4 years
measure: Quality of life assessed by KCCQ, EQ-5D and HADS
timeFrame: 4 years
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: H.C.U de Santiago de Compostela
state: A Coruña
city: Oviedo
country: Spain
facility: H.U. Central de Asturias
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: H.U. de Bellvitge
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: A Coruña
country: Spain
facility: H.U. A Coruña
state: La Coruña
city: Majadahonda
country: Spain
facility: H.U. Puerta de Hierro
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario Dr Balmis
city: Barcelona
country: Spain
facility: H.U. de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: H. Clinic de Barcelona
city: Barcelona
country: Spain
facility: H.U. Germans Trias i Pujol
city: Barcelona
country: Spain
facility: H.U. Vall d'Hebron
city: Gerona
country: Spain
facility: H.U. Josep Trueta
city: Granada
country: Spain
facility: H.U. Virgen de las Nieves
city: Lérida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: H.G.U. Gregorio Marañón
city: Madrid
country: Spain
facility: H.U. Ramón y Cajal
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: H.U. 12 de Octubre
city: Murcia
country: Spain
facility: H.C.U. Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H.U. Virgen de la Victoria
city: Palma De Mallorca
country: Spain
facility: H.U. Son Llátzer
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Salamanca
country: Spain
facility: H.U de Salamanca
city: Sevilla
country: Spain
facility: H.U. Virgen del Rocio
city: Toledo
country: Spain
facility: Complejo Hospitalario Universitario de Toledo
city: Valencia
country: Spain
facility: H.C.U de Valencia
city: Valencia
country: Spain
facility: H.U. Politécnico de la Fe
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: H.C.U de Valladolid
city: Zaragoza
country: Spain
facility: H.U. Miguel Servet
Study officials:
affiliation: H.U. Puerta de Hierro, Majadahonda
name: Pablo García Pavía
role: PRINCIPAL_INVESTIGATOR
affiliation: H.U. Germans Trias i Pujol
name: Antoni Bayés Genís
role: PRINCIPAL_INVESTIGATOR
affiliation: H.G.U. Gregorio Marañón
name: Javier Bermejo Thomas
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: Javier Díez Martínez
role: PRINCIPAL_INVESTIGATOR
References: