Patients at Risk of Heart Failure Clinical Trial
— X-HF-SPECKLEOfficial title:
Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction: Speckle Tracking Echocardiography - One Piece of the Puzzle.
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic Health System - Franciscan Healthcare | La Crosse | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Myocardial deformation | 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. | Throughout single visit (less than 1 hour) for healthy controls; 1 hour sessions before and after exercise training (3 months apart) for patients at risk of heart failure. | No |
| Secondary | Stroke volume | Stroke volume can be 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. | Throughout each testing session | No |
| Secondary | Physiological adaptation to clinical exercise | Aerobic exercise training has been shown to improve hemodynamics and quality of life in patients at risk of heart failure. Our hypothesis is that the improvement in aerobic capacity following cardiac rehabilitation will correlate with an improvement in myocardial deformation imaging, specifically strain rate. | Immediately after cardiac rehabilitation completion (Patients with heart failure only); one session, lasting 1 hour, following 3 months of cardiac rehabilitation. | No |