Heart Failure, Diastolic Clinical Trial
Official title:
Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04573166 -
Personalized Atrial Septostomy for Heart Failure
|
N/A | |
Recruiting |
NCT02425371 -
Optimized Management of Comorbidity in Heart Failure With Preserved Ejection Fraction in the Elderly (>60 Years)
|
Phase 3 | |
Terminated |
NCT03312387 -
Muscle, Essential Amino Acids, and eXercise in Heart Failure
|
N/A | |
Completed |
NCT05475028 -
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
|
||
Recruiting |
NCT04950218 -
The Psoriasis Echo Study
|
||
Completed |
NCT02334891 -
Kyoto Congestive Heart Failure Study
|
||
Recruiting |
NCT05577819 -
Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
|
N/A | |
Completed |
NCT05139472 -
Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction
|
Phase 3 | |
Recruiting |
NCT04682704 -
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
|
N/A | |
Completed |
NCT03924479 -
Respiratory Muscle Function in Heart Failure
|
N/A | |
Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
Completed |
NCT02589977 -
Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF
|
Phase 4 | |
Completed |
NCT02946476 -
Prognostic Impact of Noncardiac Comorbidities in Heart Failure Patients
|
N/A | |
Recruiting |
NCT04179643 -
NAN-101 in Patients With Class III Heart Failure
|
Phase 1 | |
Recruiting |
NCT05425459 -
RESPONDER-HF Trial
|
N/A | |
Completed |
NCT04940312 -
MyoMobile Study: App-based Activity Coaching in Patients With Heart Failure and Preserved Ejection Fraction
|
||
Recruiting |
NCT04602338 -
Diagnosis and OutcoMes evaluAtIoN of Multicenter Patients With HFpEF Using Multimodality Imaging
|
||
Completed |
NCT03240237 -
CCM in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT05887271 -
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
|
Phase 2/Phase 3 | |
Recruiting |
NCT05479669 -
Value of Intense Phenotyping in Heart Failure With Preserved Ejection Fraction
|