NCT01332162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

6.5 years

First QC Date

April 1, 2011

Last Update Submit

October 19, 2016

Conditions

Hypertrophic Obstructive Cardiomyopathy (HOCM)

Keywords

Hypertrophic Obstructive Cardiomyopathy (HOCM)Pacing

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 and 2 years

Secondary Outcomes (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.

    1 and 2 years

Study Arms (2)

Biventricular pacing

EXPERIMENTAL

All patients will be pacing during two years

Device: Biventricular pacing

No Pacing during the first year

ACTIVE COMPARATOR

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

Device: No Pacing

Interventions

Biventricular pacingDEVICE

All patients will be pacing during two years

Also known as: 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
Biventricular pacing
No PacingDEVICE

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

Also known as: 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
No Pacing during the first year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms

You may not qualify if:

  • HOCM intraventricular gradient \< 50mmHg
  • LV ejection fraction \< 50%
  • mild symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • JOSEP BRUGADA, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • ANTONIO BERRUEZO, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 8, 2011

Study Start

June 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations

ES(1)