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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
  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
Heart Failure
Other: Cardiac rehabilitation
Other: Myocardial deformation imaging
Other: Cardiopulmonary exercise test

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:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: June 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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 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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Wisconsin
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Hector Villarraga, MD Mayo Clinic
  More Information

Responsible Party: Hector R. Villarraga, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01747785     History of Changes
Other Study ID Numbers: 12-005553 
Study First Received: December 7, 2012
Last Updated: May 13, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 September 23, 2016