Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease
LVH
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this study is to determine whether vigorous exercise training 4-5 days/week for one year in sedentary middle aged (ages 40-64) individuals at high risk for future development of heart failure will improve cardiac and vascular compliance to a degree equivalent to life-long exercisers and the sedentary young. To date, no effective therapy for heart failure with preserved ejection fraction (HFpEF) has been found; therefore prevention is critical and discovering novel treatment strategies is essential. Exercise training if implemented in high risk patients may improve diastolic function and cardiac-vascular interactions, preventing further progression to overt heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 1, 2018
CompletedFirst Posted
Study publicly available on registry
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2019
CompletedOctober 14, 2019
October 1, 2019
4.1 years
March 1, 2018
October 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular stiffness
Change in ventricular stiffness after 1 year of exercise training measured as the stiffness constant of the diastolic limb of the left ventricular pressure-volume curve
1 year
Secondary Outcomes (2)
Aerobic fitness
1 year
Vascular stiffness
1 year
Study Arms (2)
High Intensity Exercise
EXPERIMENTALSubjects randomized to receive high intensity aerobic exercise will undergo exercise training for 1 year. A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded.
Yoga
PLACEBO COMPARATORSubjects randomized to yoga will receive instructions on strength and flexibility exercises.
Interventions
Subjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week.
Eligibility Criteria
You may qualify if:
- Presence of left ventricular hypertrophy (by MRI, echocardiography or ECG)
- Normal ejection fraction (\>50%)
- Elevated cardiac biomarker (high sensitivity troponin, NT-BNP)
You may not qualify if:
- age \< 40 or \>64
- body mass index\>35
- history of heart failure, myocarditis, restrictive cardiomyopathy, severe chronic obstructive pulmonary disease, unstable coronary artery disease or recent (\<12 month) acute coronary syndrome, cerebrovascular disease as evidenced by prior transient ischemic attack or stroke and active/recent tobacco use (quit \< 5 years).
- chronic orthopedic injury that precludes exercise testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231, United States
Related Publications (2)
Hieda M, Sarma S, Hearon CM Jr, MacNamara JP, Dias KA, Samels M, Palmer D, Livingston S, Morris M, Levine BD. One-Year Committed Exercise Training Reverses Abnormal Left Ventricular Myocardial Stiffness in Patients With Stage B Heart Failure With Preserved Ejection Fraction. Circulation. 2021 Sep 21;144(12):934-946. doi: 10.1161/CIRCULATIONAHA.121.054117. Epub 2021 Sep 20.
PMID: 34543068DERIVEDHieda M, Sarma S, Hearon CM Jr, Dias KA, Martinez J, Samels M, Everding B, Palmer D, Livingston S, Morris M, Howden E, Levine BD. Increased Myocardial Stiffness in Patients With High-Risk Left Ventricular Hypertrophy: The Hallmark of Stage-B Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Jan 14;141(2):115-123. doi: 10.1161/CIRCULATIONAHA.119.040332. Epub 2019 Dec 23.
PMID: 31865771DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin D Levine, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor will be blinded to subject randomization.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2018
First Posted
March 26, 2018
Study Start
June 1, 2015
Primary Completion
July 2, 2019
Study Completion
July 2, 2019
Last Updated
October 14, 2019
Record last verified: 2019-10