An interventional study of High intensity exercise and Yoga in Lv Hypertrophy, Heart Failure, Diastolic and Stiffness, Vascular, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
Among 38 studies in Hypertrophy, Left Ventricular with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Hypertrophy, Left Ventricular · United States.
Among the 38 studies in Hypertrophy, Left Ventricular with a site in United States, this one is the 16th largest by enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2015, is one of 10 with no phase, and was the 26th registered.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 56 is below the median of 100 across 97 interventional studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →7 of the 38 studies in Hypertrophy, Left Ventricular with a site in United States are open now, in 4 countries. Each count lists the studies.
Of the 20 Hypertrophy, Left Ventricular studies recruiting now, 13 (65%) set no upper age limit and 2 (10%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.
This study: 40 Years to 64 Years · all sexes · healthy volunteers too.
The full table on the hub →38 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 3 started in 2015.
Median enrollment 94 across the 26 interventional studies, 138 across the 12 observational. Of the 28 that completed or were terminated, 9 (32%) have results posted.
10 of 38 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
University of Texas Southwestern Medical Center has 2 studies filed under Hypertrophy, Left Ventricular — fewer than ten, so there is no comparison to draw.
3 of the studies in Hypertrophy, Left Ventricular with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04752293Wake Forest University Health SciencesPediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE) | 2026-12 |
| NCT05388032Tulane UniversitySodium Lowering Vascular Effects Trial | 2026-12-31 |
| NCT05593055Brigham and Women's HospitalMineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension | 2027-04-01 |
Among the 38 studies in Hypertrophy, Left Ventricular with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: High intensity exercise
Subjects randomized to yoga will receive instructions on strength and flexibility exercises.
Behavioral: Yoga
Subjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week.
Subjects will perform strength and flexibility exercises.
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
Time frame: 1 year
Aerobic fitness
Change in peak aerobic capacity (VO2) after 1 year of exercise training
Time frame: 1 year
Vascular stiffness
Change in pulse wave velocity after 1 year of exercise training
Time frame: 1 year
Plan to share: Undecided
Ran from Jun 2015 to primary completion in Jul 2019, 49 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Hypertrophy, Left Ventricular →
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