X-HF-SPECKLE: Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT01747785

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Cardiac rehabilitation Other: Myocardial deformation imaging Other: Cardiopulmonary exercise test

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 Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	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. 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.
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.	Other: Cardiac rehabilitation Aerobic cardiac exercise training will be provided over the 12 week study duration. 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. 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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Other: Cardiac rehabilitation

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

Other: Myocardial deformation imaging

Other: Cardiopulmonary exercise test

Outcome Measures

Primary Outcome Measures

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

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.