Diastolic Heart Failure Clinical Trial
Official title:
High-intensity Aerobic Interval Training vs. Moderate-intensity Continuous Exercise Training in Heart Failure With Preserved Ejection Fraction
Heart failure is a major health concern and is the leading cause of hospitalization among elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and the estimated direct and indirect costs of treating heart failure are approximately $37.2 billion. Approximately 40% of those diagnosed with heart failure will have heart failure with preserved ejection fraction (HFPEF). These individuals have significant restrictions in their ability to carry out activities of daily living. Exercise training has been established as adjuvant therapy in heart failure. Although exercise training guidelines for treatment of heart failure with reduced ejection fraction (HFREF) are well established, no consensus exercise guidelines exist for management of HFPEF. Aerobic and cardiovascular adaptations are generally greater after high-intensity exercise training; interval-type exercise facilitates this type of training because it allows for rest periods that make it possible for patients with heart failure to perform short (e.g., 1-4 minutes) work periods at intensities that are higher than would be possible during continuous exercise. High-intensity aerobic interval training presents a unique, yet untested, therapeutic modality for the exercise training of patients with heart failure with preserved ejection fraction. Pilot testing is warranted, results of which may have important implications for reducing cardiovascular risk, increasing short- and long-term quality of life and survival, and reducing healthcare costs in this patient population. The investigators primary specific aim is to determine the efficacy of a novel, high-intensity aerobic interval exercise training program for improving VO2peak (peak oxygen uptake), endothelial function, and arterial stiffness in patients with HFPEF. The investigators secondary aim is to determine whether the vascular changes are correlated with the changes in VO2peak.
Heart failure is a major health concern and is the leading cause of hospitalization among
elderly Americans. Currently 5.7 million Americans are estimated to have heart failure and
the estimated direct and indirect costs of treating heart failure are approximately $37.2
billion. Approximately 40% of those diagnosed with heart failure will have heart failure with
preserved ejection fraction (HFPEF).2 These individuals have significant restrictions in
their ability to carry out activities of daily living.
Exercise training has been established as adjuvant therapy in heart failure.4 Although
exercise training guidelines for treatment of heart failure with reduced ejection fraction
(HFREF) are well established, no consensus exercise guidelines exist for management of HFPEF.
Exercise training increases VO2peak, thus improving prognosis for patients with heart
failure. Indeed, VO2peak has been reported to be the single best predictor of mortality in
those with cardiac disease.6 Exercise training also improves endothelial function and reduces
arterial stiffness, as well as enhancing quality of life.7,8 Because HFPEF is associated with
a both diastolic dysfunction and a loss of compensatory systemic vasodilator reserves,
arterial stiffness and endothelial function are especially important in this population.
Aerobic and cardiovascular adaptations are generally greater after high-intensity exercise
training; interval-type exercise facilitates this type of training because it allows for rest
periods that make it possible for patients with heart failure to perform short (e.g., 1-4
minutes) work periods at intensities that are higher than would be possible during continuous
exercise. For example, Wisloff et al. demonstrated the superiority of high-intensity aerobic
interval training, as compared to continuous, moderate-intensity exercise training, in
patients with stable postinfarction heart failure (with reduced ejection fraction). Not only
was VO2peak and FMD improved more, patients tolerated the high-intensity program without
reported incident. Furthermore, they found it "motivating to have a varied procedure to
follow," whereas patients found the continuous exercise group training sessions to be "quite
boring." High-intensity aerobic interval training presents a unique, yet untested,
therapeutic modality for the exercise training of patients with heart failure with preserved
ejection fraction.
Pilot testing is warranted, results of which may have important implications for reducing
cardiovascular risk, increasing short- and long-term quality of life and survival, and
reducing healthcare costs in this patient population.Patients undergoing exercise training
live on average 2.16 years longer at the extremely low cost-effectiveness ratio of $1494 per
life year saved.Since the majority of this patient population belongs to the Medicare age
group, this intervention has significant potential to reduce healthcare costs.
Hypotheses and Specific Aims Our primary specific aim is to determine the efficacy of a
novel, high-intensity aerobic interval exercise training program for improving VO2peak,
endothelial function, and arterial stiffness in patients with HFPEF. Our secondary aim is to
determine whether the vascular changes are correlated with the changes in VO2peak.
We hypothesize that improvements in VO2peak, endothelial function, and arterial stiffness
will be greater after the high-intensity aerobic interval training program and that vascular
adaptations will be correlated with changes in VO2peak.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02499601 -
CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
|
N/A | |
Completed |
NCT02537041 -
Non-invasive Evaluation of Myocardial Stiffness by Elastography
|
N/A | |
Completed |
NCT02275793 -
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
|
||
Withdrawn |
NCT00773084 -
Aliskiren and Renin Inhibition in Diastolic Heart Failure
|
N/A | |
Terminated |
NCT00293150 -
Reversing Endothelial and Diastolic Dysfunction and Improving Collagen Turnover in Diastolic Heart Failure
|
Phase 4 | |
Terminated |
NCT01942395 -
Dietary Approaches to Stop Hypertension in 'Diastolic' Heart Failure 2 (DASH-DHF 2)
|
N/A | |
Recruiting |
NCT03157219 -
Manipal Heart Failure Registry (MHFR)
|
N/A | |
Terminated |
NCT01778894 -
Mathematical Modeling to Determine Basic Muscle Properties in the Failing Heart
|
||
Completed |
NCT04154878 -
2 New Measurements Used to Describe the Filling Phase of the Left Ventricle (LV).
|
||
Recruiting |
NCT01599117 -
A Randomized Trial of Udenafil Therapy in Patients With Heart Failure With Preserved Ejection Fraction [ULTIMATE-HFpEF]
|
Phase 3 | |
Completed |
NCT01185067 -
Physiological Effects of Grape Seed Extract in Diastolic Heart Failure
|
Phase 1 | |
Completed |
NCT03338374 -
Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Completed |
NCT02589977 -
Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
|
Phase 4 | |
Terminated |
NCT00083772 -
Use of Nesiritide in the Management of Acute Diastolic Heart Failure
|
Phase 4 | |
Completed |
NCT00303498 -
A Study of the Effectiveness of Sitaxsentan Sodium in Patients With Diastolic Heart Failure
|
Phase 2 | |
Terminated |
NCT02254382 -
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
|
N/A | |
Completed |
NCT00839228 -
Perhexiline Therapy in Heart Failure With Preserved Ejection Fraction Syndrome
|
Phase 2 | |
Terminated |
NCT00662116 -
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
|
Phase 2 | |
Completed |
NCT02084992 -
A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure
|
N/A | |
Completed |
NCT02916225 -
High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction
|
N/A |