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

ConditionNon-ischemic Dilated Cardiomyopathy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Control Strategy

    Other intervention

    ICDs will be implanted in all patients according to current recommendations

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

    Other intervention

    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.

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Control StrategyOther 1 intervention
Group B: Personalized precision ICD implantation Strategy based in genetic findings and CMR resultsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite end-point of all cause death, hospitalization due to device-related complications, and non-fatal major arrhythmic events.

Time frame
4 years

Secondary outcomes

1

All-cause death

Time frame
4 years
2

SCD

Time frame
4 years
3

Hospitalisation for device-related complications

Time frame
4 years
4

Non-fatal major arrhythmic events

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Source ClinicalTrials.gov
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