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

NCT06055504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2024-02-28

No results posted yet for this study

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%

Conditions

  • Non-ischemic Dilated Cardiomyopathy

Interventions

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    lead OTHER_GOV

Principal Investigators

  • Pablo García Pavía · H.U. Puerta de Hierro, Majadahonda

  • Antoni Bayés Genís · H.U. Germans Trias i Pujol

  • Javier Bermejo Thomas · H.G.U. Gregorio Marañón

  • Javier Díez Martínez · University of Navarra

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2025-10-01
Completion
2027-10-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055504 on ClinicalTrials.gov