Back to resultsDiastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiac Resynchronisation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- Symptomatic Hypertrophic Cardiomyopathy,
Exclusion Criteria:
- Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.
Sites / Locations
- Department Cardiovascular Medicine, University of BirminghamRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cardiac Resynchronisation Therapy
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00698074
First Posted
June 11, 2008
Last Updated
June 13, 2008
Sponsor
University Hospital Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00698074
Brief Title
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
Official Title
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Birmingham
4. Oversight
5. Study Description
Brief Summary
The primary aim of this study will be to assess whether Biventricular pacing improves exercise capacity, and Quality of Life in patients with symptomatic drug resistant Non-Obstructive Hypertrophic Cardiomyopathy, using a Biventricular pacemaker.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cardiac Resynchronisation Therapy
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronisation Therapy
Intervention Description
Biventricular Pacemaker Implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic Hypertrophic Cardiomyopathy,
Exclusion Criteria:
Rhythm other than normal sinus Left ventricular outflow tract gradient greater than 30mmHg Inability to exercise v02 max greater than 70% of predicted.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael P Frenneaux, MBBS
Phone
121-414-5916
Ext
5916
Email
m.p.frenneaux@bham.ac.uk
Facility Information:
Facility Name
Department Cardiovascular Medicine, University of Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ibrar ahmed, MBChB
Phone
121-414-5916
Email
01ahmedi@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Diastolic Ventricular Interaction and the Effects of Biventricular Pacing in Hypertrophic Cardiomyopathy
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