CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Hospital Clinic of Barcelona

Status and phase: Unknown; Phase 2

Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)

Treatments: Device: No Pacing; Device: Biventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT01332162

CRT-01-2011-HCPB

Details and patient eligibility

About

The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

Full description

In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

Exclusion criteria

• HOCM intraventricular gradient < 50mmHg
• LV ejection fraction < 50%
• mild symptoms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Biventricular pacing

Experimental group

Description:

All patients will be pacing during two years

Treatment:

Device: Biventricular pacing

No Pacing during the first year

Active Comparator group

Description:

No Pacing during the first year. In the second year all patients will be pacing

Treatment:

Device: No Pacing