Status:
RECRUITING
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
Lead Sponsor:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Non-ischemic Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 dilate...
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 L...
Eligibility Criteria
Inclusion
- 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.
- LVEF ≤ 35% documented by CMR as study procedure.
- Life expectancy greater than 12 months.
Exclusion
- 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.
- NYHA functional class IV.
- Waiting list for cardiac transplantation in emergency 0.
- Receiver of a solid organ transplant (lung, liver, heart or kidney).
Key Trial Info
Start Date :
September 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT06055504
Start Date
September 6 2023
End Date
October 1 2027
Last Update
February 28 2024
Active Locations (31)
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1
H.C.U de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
2
H.U. de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
4
H.U. A Coruña
A Coruña, La Coruña, Spain, 15006