NCT06055504

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-ischemic Dilated Cardiomyopathy

Interventions

Type	Name	Description
OTHER	Control Strategy	ICDs will be implanted in all patients according to current recommendations
OTHER	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.

Timeline

• Start date: 2023-09-06
• Primary completion: 2025-10-01
• Completion: 2027-10-01
• First posted: 2023-09-26
• Last updated: 2024-02-28

Locations

31 sites across 1 country: Spain