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

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Status

Enrolling

Conditions

Non-ischemic Dilated Cardiomyopathy

Treatments

Other: Personalized precision ICD implantation Strategy based in genetic findings and CMR results

Other: Control Strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT06055504

SPANISH-1

Details and patient eligibility

About

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%

Full 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.

Enrollment

900 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).