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

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Biventricular pacing

No Pacing

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy (HOCM) focused on measuring Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Clinic i Provincial de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biventricular pacing

No Pacing during the first year

Arm Description

All patients will be pacing during two years

No Pacing during the first year. In the second year all patients will be pacing

Outcomes

Primary Outcome Measures

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

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.

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.

Full Information

NCT ID

NCT01332162

First Posted

April 1, 2011

Last Updated

October 19, 2016

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01332162

Brief Title

CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

Acronym

CARDIO-HCM

Official Title

CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Keywords

Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biventricular pacing

Arm Type

Experimental

Arm Description

All patients will be pacing during two years

Arm Title

No Pacing during the first year

Arm Type

Active Comparator

Arm Description

No Pacing during the first year. In the second year all patients will be pacing

Intervention Type

Device

Intervention Name(s)

Biventricular pacing

Other Intervention Name(s)

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

Intervention Description

All patients will be pacing during two years

Intervention Type

Device

Intervention Name(s)

No Pacing

Other Intervention Name(s)

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

Intervention Description

No Pacing during the first year. In the second year all patients will be pacing

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 and 2 years

Secondary Outcome Measure Information:

Title

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.

Description

Time Frame

1 and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JOSEP BRUGADA, MD, PhD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

ANTONIO BERRUEZO, MD

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clinic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Josep Brugada, MD. PhD.

Phone

+34932275703

jbrugada@clinic.ub.es

First Name & Middle Initial & Last Name & Degree

Dr.Antonio Berruezo, MD. PhD.

Phone

+34 93 2275551

aberruezo@clinic.ub.es

First Name & Middle Initial & Last Name & Degree

Dr. Josep Brugada, MD. PhD.

12. IPD Sharing Statement

Learn more about this trial

CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM

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