CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Phase 2

• Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)
• Interventions: Device: Biventricular pacing; Device: No Pacing

• Registration Number: NCT01332162
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Study Start: 2013-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-20
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biventricular pacing	Biventricular pacing	All patients will be pacing during two years
No Pacing during the first year	No Pacing	No Pacing during the first year. In the second year all patients will be pacing

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).	1 and 2 years	Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.	1 and 2 years	Change from Baseline in Clinical evaluation (New York Heart Association(NYHA), Quality of life Questionnaire (QoL), 6 Minutes Walk Test (6MWT)), interventricular septum thickness, posterior wall thickness, provoked left ventricular outflow tract gradient, mitral regurgitation grade.

Trial Locations

Locations (1)

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain