CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

April 1, 2011
March 19, 2013
June 2013
December 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01332162 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM
CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertrophic Obstructive Cardiomyopathy (HOCM)
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
December 2017
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Spain
 
NCT01332162
CRT-01-2011-HCPB
No
Josep Brugada, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: JOSEP BRUGADA, MD, PhD HOSPITAL CLINIC DE BARCELONA
Principal Investigator: ANTONIO BERRUEZO, MD HOSPITAL CLÍNIC DE BARCELONA
Hospital Clinic of Barcelona
April 2011

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