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CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM (CARDIO-HCM)

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ClinicalTrials.gov Identifier: NCT01332162
Recruitment Status : Recruiting
First Posted : April 8, 2011
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Josep Brugada, 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.

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy (HOCM) Device: Biventricular pacing Device: No Pacing Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy
Study Start Date : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Biventricular pacing
All patients will be pacing during two years
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
Active Comparator: No Pacing during the first year
No Pacing during the first year. In the second year all patients will be pacing
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



Primary Outcome Measures :
  1. Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg). [ Time Frame: 1 and 2 years ]
    Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332162


Locations
Spain
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Dr. Josep Brugada, MD. PhD.    +34932275703    jbrugada@clinic.ub.es   
Contact: Dr.Antonio Berruezo, MD. PhD.    +34 93 2275551    aberruezo@clinic.ub.es   
Principal Investigator: Dr. Josep Brugada, MD. PhD.         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: JOSEP BRUGADA, MD, PhD Hospital Clinic of Barcelona
Principal Investigator: ANTONIO BERRUEZO, MD HOSPITAL CLÍNIC DE BARCELONA

Responsible Party: Josep Brugada, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01332162     History of Changes
Other Study ID Numbers: CRT-01-2011-HCPB
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016

Keywords provided by Josep Brugada, Hospital Clinic of Barcelona:
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Pacing

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases