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

October 19, 2016 updated by: Josep Brugada, Hospital Clinic of Barcelona

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic i Provincial de Barcelona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Josep Brugada, MD. PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: JOSEP BRUGADA, MD, PhD, Hospital Clinic of Barcelona
  • Principal Investigator: ANTONIO BERRUEZO, MD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-01-2011-HCPB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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