Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction
NCT ID: NCT01747785
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
21 participants
OBSERVATIONAL
2012-06-30
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy controls
Individuals without history of cardiovascular disease and at least 18 years of age will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 3 visits over a 12 week period.
Myocardial deformation imaging
A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.
Cardiopulmonary exercise test
The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.
Patients at risk of heart failure
Individuals at risk of heart failure and a preserved ejection fraction of at least 50% will take a baseline (at rest) cardiopulmonary exercise test (CPX) and have a baseline cardiac echocardiogram to measure myocardial deformation. CPX and echocardiograms will be repeated during exercise sessions at 6 visits over a 12 week period. A cardiac rehabilitation exercise program will also occur over 12 weeks.
Cardiac rehabilitation
Aerobic cardiac exercise training will be provided over the 12 week study duration.
Myocardial deformation imaging
A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.
Cardiopulmonary exercise test
The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.
Interventions
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Cardiac rehabilitation
Aerobic cardiac exercise training will be provided over the 12 week study duration.
Myocardial deformation imaging
A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.
Cardiopulmonary exercise test
The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.
Eligibility Criteria
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Inclusion Criteria
* able to exercise on a bicycle
Exclusion Criteria
* severe chronic obstructive pulmonary disease,
* congenital heart abnormalities,
* infiltrative or hypertrophic cardiomyopathy.
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Hector R. Villarraga, M.D.
PI
Principal Investigators
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Hector Villarraga, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States
Countries
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Other Identifiers
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12-005553
Identifier Type: -
Identifier Source: org_study_id
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