Angiogenesis Modulated by EPC Clinical Trial
Official title:
Effects of Aerobic Interval and Continuous Exercise Trainings on Cardiovascular Hemorheological Characteristics and Atherothrombosis/Angiogenesis-related Variables in Patients With Chronic Heart Failure
Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the
end result of many cardiovascular disorders. It has been reported that HF patients with
pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise
tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is
associated with neurohumoral changes as the body attempts to reverse the effect of reduced
cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually
results in deterioration of myocardial function with inflammatory response, end-organ
damage, and skeletal muscle derangement, which lead to worsened exercise capacity.
Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and
central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular
function, leading to improvement in functional capacity and quality of life. All these
training-induced changes can effectively counteract the progression of deleterious
compensatory mechanisms of HF.
Several lines of evidence suggest greater aerobic and cardiovascular adaptations after
high-intensity exercise than with moderate levels in patients with coronary artery disease
or left ventricular dysfunction function and in healthy subjects. Aerobic interval training
(AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte
contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial
natriuretic peptide in animal model of post-infarction heart failure. However, underlying
mechanisms of AIT-improved regulations remain unclear.
The different effects of AIT and moderate continuous training (MCT) on hemorheology,
atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with
CHF have been not investigated yet. Accordingly, the investigators will conduct this
three-year study to clarify how the two exercise trainings affect cardiovascular
hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in
patients with chronic heart failure. The investigators expect that these results obtained
from this study can aid in determining appropriate exercise intervention to improve aerobic
fitness as well as simultaneously improve hemodynamic control and minimize the risk of
thrombogenesis in patients with CHF.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - cardiac event with optimal medial treatment within 3 months and have 4 more weeks spared from heart disease attack or major cardiac procedure. Exclusion Criteria: - unstable angina pectoris, - uncompensated heart failure, - myocardial infarction during the past 4 weeks, - complex ventricular arrhythmias, - orthopedic or neurological limitations to exercise |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chang Gung University | Kwei-Shan. | Tao-Yuan |
| Lead Sponsor | Collaborator |
|---|---|
| Chang Gung Memorial Hospital | Chang Gung University, National Science Council, Taiwan |
Taiwan,
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Engoren M, Barbee D. Comparison of cardiac output determined by bioimpedance, thermodilution, and the Fick method. Am J Crit Care. 2005 Jan;14(1):40-5. — View Citation
Ribeiro JP, Stein R, Chiappa GR. Beyond peak oxygen uptake: new prognostic markers from gas exchange exercise tests in chronic heart failure. J Cardiopulm Rehabil. 2006 Mar-Apr;26(2):63-71. Review. — View Citation
Rognmo Ø, Hetland E, Helgerud J, Hoff J, Slørdahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004 Jun;11(3):216-22. — View Citation
Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. Epub 2007 Jun 4. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ventilation efficacy | Ventilation efficacy could be show as ventilation equivalent(minute ventilation / oxygen consumption (VE/VO2) or minute ventilation / Carbon dioxide production (VE/VCO2). The slope of VE/VCO2 predict mortality in HF patient. These data ia available during cardiopulmonary exercise test(CPX or CPET). We also got other traditional data including Peak HR, Peak O2 consumption, Peak workload...... | three year | Yes |