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

This study is currently recruiting participants.
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
  Purpose

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 Intervention
Patients at Risk of Heart Failure
Other: Cardiac rehabilitation
Other: Myocardial deformation imaging

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 25
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy controls
Individuals without history of cardiovascular disease and at least 18 years of age.
Other: Myocardial deformation imaging
Patients at risk of heart failure
Individuals at risk of heart failure and an ejection fraction of at least 50%.
Other: Cardiac rehabilitation Other: Myocardial deformation imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747785

Contacts
Contact: Terri Pedace 608-392-9462

Locations
United States, Wisconsin
Mayo Clinic Health System - Franciscan Healthcare Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Terry Pedace    608-392-9462      
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Charles E. Luoma, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01747785     History of Changes
Other Study ID Numbers: 12-005553
Study First Received: December 7, 2012
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Heart failure
HFpEF
Dyspnea
Fatigue
Shortness of Breath
exercise
strain
myocardial deformation
cardiac rehabilitation
cardiac hemodynamics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014