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

This study has been terminated.
(Study stopped for administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Hector R. Villarraga, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01747785
First received: December 7, 2012
Last updated: May 13, 2016
Last verified: January 2016

December 7, 2012
May 13, 2016
June 2012
July 2015   (final data collection date for primary outcome measure)
Change in mean cardiac reserve as measured by strain rate [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
Myocardial deformation [ Time Frame: Throughout single visit (less than 1 hour) for healthy controls; 1 hour sessions before and after exercise training (3 months apart) for patients with heart failure. ] [ Designated as safety issue: No ]
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 with heart failure demonstrating lack of cardiovascular reserve.
Complete list of historical versions of study NCT01747785 on ClinicalTrials.gov Archive Site
Change in mean cardiac stroke volume [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
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.
  • Stroke volume [ Time Frame: Throughout each testing session ] [ Designated as safety issue: No ]
    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 with heart failure and this plateau will correlate with a reduction in strain rate.
  • Physiological adaptation to clinical exercise [ Time Frame: Immediately after cardiac rehabilitation completion (Patients with heart failure only); one session, lasting 1 hour, following 3 months of cardiac rehabilitation. ] [ Designated as safety issue: No ]
    Aerobic exercise training has been shown to improve hemodynamics and quality of life in patients with 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.
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Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Community sample
Heart Failure
  • 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.
  • 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.
    Interventions:
    • Other: Myocardial deformation imaging
    • Other: Cardiopulmonary exercise test
  • 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.
    Interventions:
    • Other: Cardiac rehabilitation
    • Other: Myocardial deformation imaging
    • Other: Cardiopulmonary exercise test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01747785
12-005553
No
No
Not Provided
Hector R. Villarraga, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Hector Villarraga, MD Mayo Clinic
Mayo Clinic
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP