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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)

About this trial

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%

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Control Strategy
  • Personalized precision ICD implantation Strategy based in genetic findings and CMR results

Treatment groups

900 Participants
are divided into 2 treatment groups

Sponsors and collaborators