CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

This study is not yet open for participant recruitment.

Verified April 2011 by Hospital Clinic of Barcelona

Sponsor:

Information provided by (Responsible Party):

Josep Brugada, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT01332162

First received: April 1, 2011

Last updated: March 19, 2013

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2011

Last Updated Date

March 19, 2013

Start Date ^ICMJE

June 2013

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg). [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01332162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Official Title ^ICMJE

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Intervention ^ICMJE

Device: Biventricular pacing
All patients will be pacing during two years
Other Names:
- CRT-D and CRT-P devices:
- Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical
- Promote Q CD3221-36. St. Jude Medical
- Pacemaquer:
- Anthem PM3112. St. Jude Medical
Device: No Pacing
No Pacing during the first year. In the second year all patients will be pacing
Other Names:
- CRT-D and CRT-P devices:
- Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical
- Promote Q CD3221-36. St. Jude Medical
- Pacemaquer:
- Anthem PM3112. St. Jude Medical

Study Arm (s)

Experimental: Biventricular pacing
All patients will be pacing during two years

Intervention: Device: Biventricular pacing
Active Comparator: No Pacing during the first year
No Pacing during the first year. In the second year all patients will be pacing

Intervention: Device: No Pacing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01332162

Other Study ID Numbers ^ICMJE

CRT-01-2011-HCPB

Has Data Monitoring Committee

Responsible Party

Josep Brugada, Hospital Clinic of Barcelona

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	JOSEP BRUGADA, MD, PhD	HOSPITAL CLINIC DE BARCELONA
Principal Investigator:	ANTONIO BERRUEZO, MD	HOSPITAL CLÍNIC DE BARCELONA

Information Provided By

Hospital Clinic of Barcelona

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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