Have you or your loved ones been diagnosed with hypertrophic obstructive cardiomyopathy?

You may be eligible to participate in a hypertrophic obstructive cardiomyopathy clinical trial.

Have you or your loved ones been diagnosed with hypertrophic obstructive cardiomyopathy? You may be eligible to participate in a hypertrophic obstructive cardiomyopathy clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Hypertrophic Obstructive Cardiomyopathy Clinical Trial in Barcelona

NCT01332162 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with hypertrophic obstructive cardiomyopathy?

You may be eligible to participate in a hypertrophic obstructive cardiomyopathy clinical trial.

Have you or your loved ones been diagnosed with hypertrophic obstructive cardiomyopathy? You may be eligible to participate in a hypertrophic obstructive cardiomyopathy clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 80 Participants

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.

Show me more details

Details for the study

Brief Title

CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Official Title

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Brief Summary

The purpose of this study is to evaluate the benefit of the optimal pacing configuration,<br /> including the possibility of biventricular or left ventricular pacing, in hypertrophic<br /> 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.

Treatments and/or Procedures

Biventricular pacing

All patients will be pacing during two years

No pacing

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).

Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)

1 and 2 years

Secondary

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.

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.

1 and 2 years

Study Criteria

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