Lv HypertrophyLVHNCT03476785
Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease
A study testing High intensity exercise and Yoga in people with Lv Hypertrophy and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Lv Hypertrophy, Heart Failure, Diastolic, Stiffness, Vascular
- What is being tested?
- High intensity exercise and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 2 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of left ventricular hypertrophy (by MRI, echocardiography or ECG)
- Normal ejection fraction (>50%)
- Elevated cardiac biomarker (high sensitivity troponin, NT-BNP)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
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.
Read the 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.
- Being tested
- High intensity exercise, Yoga
- Keywords
- LVH, Ventricular Stiffness, Fitness, HFpEF
- Medical subject headings
- Hypertrophy, Left Ventricular, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
Subjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week.
YogaBehavioural
Subjects will perform strength and flexibility exercises.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Exercise | Experimental | 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. Receives: Behavioral: High intensity exercise |
| Yoga | Placebo comparator | Subjects randomized to yoga will receive instructions on strength and flexibility exercises. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Aerobic fitness
Change in peak aerobic capacity (VO2) after 1 year of exercise training
Measured: 1 year
Vascular stiffness
Change in pulse wave velocity after 1 year of exercise training
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jun 2015
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lv HypertrophyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin D Levine, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476785
- Sponsor's protocol ID
- STU 062014-068
- Acronym
- LVH
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2018
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kyrouac D, Talbot N, MacNamara J, Howden E, Hieda M, Hearon C, Brazile T, Levine B, Sarma S. Effects of Year Long Aerobic Exercise on Left Atrial Size in Patients With Left Ventricular Hypertrophy. Am J Cardiol. 2025 Jun 1;244:3-8. doi: 10.1016/j.amjcard.2025.02.020. Epub 2025 Feb 20.
PubMed 39986446Hieda 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.
PubMed 34543068Hieda 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.
PubMed 31865771
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease
- ClinicalTrials.gov ID
- NCT03476785
- Acronym / sponsor ID
- LVH / STU 062014-068
- Keywords
- LVH, Ventricular Stiffness, Fitness, HFpEF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| High Intensity Exercise | Experimental | Behavioral: High intensity exerciseSubjects 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 comparator | Behavioral: YogaSubjects randomized to yoga will receive instructions on strength and flexibility exercises. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of left ventricular hypertrophy (by MRI, echocardiography or ECG)
- Normal ejection fraction (>50%)
- Elevated cardiac biomarker (high sensitivity troponin, NT-BNP)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity exerciseSubjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week. | Behavioural | High Intensity Exercise |
| YogaSubjects will perform strength and flexibility exercises. | Behavioural | Yoga |
Primary outcome
Left ventricular stiffness
Time frame: 1 year
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
2 secondary outcomes
Aerobic fitness
Time frame: 1 year
Vascular stiffness
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Derived from this study: PubMed 39986446Kyrouac D, Talbot N, MacNamara J, Howden E, Hieda M, Hearon C, Brazile T, Levine B, Sarma S. Effects of Year Long Aerobic Exercise on Left Atrial Size in Patients With Left Ventricular Hypertrophy. Am J Cardiol. 2025 Jun 1;244:3-8. doi: 10.1016/j.amjcard.2025.02.020. Epub 2025 Feb 20.
- Derived from this study: PubMed 34543068Hieda 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.
- Derived from this study: PubMed 31865771Hieda 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin D Levine, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exercise and Yoga in people with Lv Hypertrophy and Heart Failure, Diastolic, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular stiffness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476785, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.