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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Charles E. Luoma, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01747785
First received: December 7, 2012
Last updated: February 14, 2014
Last verified: February 2014

December 7, 2012
February 14, 2014
June 2012
September 2014   (final data collection date for primary outcome measure)
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 at risk of 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 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
  • 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 at risk of 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 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.
  • 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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Community sample

Patients at Risk of Heart Failure
  • Other: Cardiac rehabilitation
  • Other: Myocardial deformation imaging
  • Healthy controls
    Individuals without history of cardiovascular disease and at least 18 years of age.
    Intervention: Other: Myocardial deformation imaging
  • Patients at risk of heart failure
    Individuals at risk of heart failure and an ejection fraction of at least 50%.
    Interventions:
    • Other: Cardiac rehabilitation
    • Other: Myocardial deformation imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
September 2014
September 2014   (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
Yes
Contact: Terri Pedace 608-392-9462
United States
 
NCT01747785
12-005553
Not Provided
Charles E. Luoma, Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
February 2014

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