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

Study Overview
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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.

Official Title
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Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction: Speckle Tracking Echocardiography - One Piece of the Puzzle.

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Cardiac rehabilitation
* Other: Myocardial deformation imaging
* Other: Cardiopulmonary exercise test


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br>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. | Other: Myocardial deformation imaging<br>* 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.<br>Other: Cardiopulmonary exercise test<br>* 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.<br>|
| Patients at risk of heart failure<br>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. | Other: Cardiac rehabilitation<br>* Aerobic cardiac exercise training will be provided over the 12 week study duration.<br>Other: Myocardial deformation imaging<br>* 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.<br>Other: Cardiopulmonary exercise test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean cardiac reserve as measured by strain rate | Myocardial deformation imaging (e.g. strain, strain rate, torsion) requires clear 2-dimensional echocardiography images that will be obtain at rest and during mild and moderate intensity exercise. Images will be captured during 6-10 minute bouts of exercise on a tilting exercise table. Comparisons will be made on resting and exercise values between groups. Our hypothesis is that strain rate will not increase in patients at risk of heart failure demonstrating lack of cardiovascular reserve. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean cardiac stroke volume | Stroke volume is the volume of blood (in milliliters) ejected during each heart contraction, It is measured by combined Doppler and 2-dimensional echocardiography. A surrogate measure of stroke volume (oxygen-pulse) can also be obtained during cardiopulmonary exercise testing by dividing the measured oxygen consumption by the heart rate. Our hypothesis is that stroke volume will plateau early after exercise onset in patients at risk of heart failure and this plateau will correlate with a reduction in strain rate. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, Heart failure, HFpEF, Dyspnea, Fatigue, Shortness of Breath, strain, myocardial deformation, cardiac rehabilitation, cardiac hemodynamics