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

Non-ischemic Dilated Cardiomyopathy Clinical Trial

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

Status Recruiting

Clinical Trial 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%

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure
• Non-ischemic Dilated Cardiomyopathy

• NCT number: NCT06055504
• Study type: Interventional
• Source: Consorcio Centro de Investigación Biomédica en Red (CIBER)
• Contact: Maria de la Iglesia
• Phone: +34911916749
• Email: spanish-i@cibercv.es
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2023
• Completion date: October 1, 2027