- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476785
Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease (LVH)
Study Overview
Status
Intervention / Treatment
Detailed Description
The global objective of this project is to test novel strategies to prevent diastolic dysfunction associated with HFpEF; these include: a) identifying high risk individuals by using population derived imaging and blood biomarkers; and b) implementing novel exercise training strategies in these middle age individuals, when cardiac plasticity still exists, to forestall the development of diastolic abnormalities that progress to HFpEF.
Prior research has demonstrated that: a) healthy but sedentary aging leads to atrophy and stiffening of the heart with reduced myocardial and chamber compliance; b) in contrast, highly competitive senior athletes had cardiac compliance that was indistinguishable from healthy young individuals suggesting that lifelong exercise training prevented this stiffening; c) even prolonged and intense exercise training started after age 65 failed to reverse age-related cardiac and vascular stiffening; d) cardiac stiffening begins in middle age (40-64) and can be substantially prevented by training 4-5 days/wk. The primary objective of this project is therefore to identify high risk sedentary individuals age 40-64, and initiate an exercise program carefully designed to maximize effects on cardiovascular compliance and function. Findings from this aim would have enormous public health significance and establish a novel, practical exercise training strategy designed to reverse cardiovascular stiffening.
Hypothesis:
Exercise training, when implemented 4-5 times/week over a prolonged period of time in sedentary high risk middle aged men and women, age 40-64 will improve cardiac and vascular compliance to a degree equivalent to life-long exercisers (and sedentary young);
Specific Aim:
To test the hypothesis, two groups of previously sedentary subjects, ages 40-64 at particularly high risk for HF will be studied for one year, with the following interventions: 1) subjects undergoing prolonged endurance/interval/strength exercise training; and 2) strength and flexibility /balance control. Subjects will be categorized as high risk and enrolled on the basis of elevated serum biomarkers and left ventricular hypertrophy (LVH) documented by cardiac MRI. Comprehensive invasive and non-invasive assessment of cardiovascular structure and systolic/diastolic function will be performed before and after 1 year of an exercise intervention involving high intensity aerobic intervals, lower intensity endurance training, and strength training, compared with strength and flexibility control.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75231
- The Institute for Exercise and Environmental Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presence of left ventricular hypertrophy (by MRI, echocardiography or ECG)
- Normal ejection fraction (>50%)
- Elevated cardiac biomarker (high sensitivity troponin, NT-BNP)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Intensity Exercise
Subjects 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.
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Subjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week.
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PLACEBO_COMPARATOR: Yoga
Subjects randomized to yoga will receive instructions on strength and flexibility exercises.
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Subjects will perform strength and flexibility exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left ventricular stiffness
Time Frame: 1 year
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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
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic fitness
Time Frame: 1 year
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Change in peak aerobic capacity (VO2) after 1 year of exercise training
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1 year
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Vascular stiffness
Time Frame: 1 year
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Change in pulse wave velocity after 1 year of exercise training
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1 year
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Hieda 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 062014-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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