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
Sponsors and collaborators
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead sponsor
Instituto de Salud Carlos III
Collaborator