Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction

NCT ID: NCT01747785

Last Updated: 2016-05-17

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-07-31

Brief Summary

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This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.

Detailed Description

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Heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. This study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. Participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Aerobic cardiac exercise training will be provided over the 12 week study duration.

Myocardial deformation imaging

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older,
* able to exercise on a bicycle

Exclusion Criteria

* heart arrhythmias,
* severe chronic obstructive pulmonary disease,
* congenital heart abnormalities,
* infiltrative or hypertrophic cardiomyopathy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Hector R. Villarraga, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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12-005553

Identifier Type: -

Identifier Source: org_study_id

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