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
  Purpose

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 Intervention Phase
Hypertrophic Obstructive Cardiomyopathy (HOCM)
Device: Biventricular pacing
Device: No Pacing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332162

Locations
Spain
Hospital Clinic i Provincial de Barcelona Not yet 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 DE BARCELONA
Principal Investigator: ANTONIO BERRUEZO, MD HOSPITAL CLÍNIC DE BARCELONA
  More Information

No publications provided

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
Study First Received: April 1, 2011
Last Updated: March 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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

ClinicalTrials.gov processed this record on August 20, 2014