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

Terminated

• Conditions: Heart Failure
• Interventions: Other: Cardiac rehabilitation; Other: Myocardial deformation imaging; Other: Cardiopulmonary exercise test

• Registration Number: NCT01747785
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Read More

Exclusion Criteria

• heart arrhythmias,
• severe chronic obstructive pulmonary disease,
• congenital heart abnormalities,
• infiltrative or hypertrophic cardiomyopathy.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients at risk of heart failure	Cardiac rehabilitation	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.
Patients at risk of heart failure	Myocardial deformation imaging	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.
Healthy controls	Myocardial deformation imaging	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.
Healthy controls	Cardiopulmonary exercise test	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.
Patients at risk of heart failure	Cardiopulmonary exercise test	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.

Primary Outcome Measures

Name	Time	Method
Change in mean cardiac reserve as measured by strain rate	Baseline, 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in mean cardiac stroke volume	Baseline, 12 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic Health System - Franciscan Healthcare; 🇺🇸 La Crosse, Wisconsin, United States