Ischemic Reperfusion Injury Clinical Trial
Official title:
The Role of Exercise-Periodic-Breathing in Impaired Ventilation Regulation Dysfunction in Patients With Heart Failure
NCT number | NCT01454128 |
Other study ID # | 99-2546B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2011 |
Est. completion date | March 2013 |
Verified date | May 2019 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Heart failure (HF) is a complex syndrome characterized by myocardial dysfunction and an
impaired regulatory function of multiple organ systems which were resulted from impaired
cardiac output and consequently impaired perfusion of target organ. In cardiopulmonary
exercise test (CPET), the investigators found there is periodic oscillation in minute
ventilation of some patient. With periodic breathing (PB), clear oscillations in oxygen
uptake, carbon dioxide output, tidal volume and left ventricle ejection fraction (LVEF) were
also noted. Exertional hyper-ventilation that is caused by HF may further induce
vasoconstriction during exercise and lead to further dysfunction of end-organ and muscle.
Reduced end-organ perfusion/oxygenation may critically limit exercise performance. Hypoxic
change during nadir phase of PB may deteriorate the exercise limitation. Physical training
can have beneficial effects which can effectively counteract the progression of deleterious
compensatory mechanisms of HF. Whether exercise yields the same beneficial effect on
ventilation oscillation and inefficacy is not clear.
The investigators will observe the real-time cardiac and hemodynamic change respond to
exercise with periodic breathing change. 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 in patients with HF. A
quasi-experimental design will be used in this investigation. 60 HF patients will be
recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided
informed consent. These subjects will be divided into PB (n=30) and non-PB groups (n=30) by
their expression of CPET. Patients from each groups received the same therapy and trace
course for 2years including CV clinics, CPET and polysomnography. The investigators will
measure subjects' physical fitness, oxygen transport and utilization of exercising skeletal
muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and
aggregation, plasma biomarkers of myocardial damage, oxygen stress and quality of life at
pre-training stage and following the 6th , 12th, 18th, 24th months of the tracing program.
Experimental results were analyzed by descriptive statistics, independent t-test, and
repeated measure ANOVA. The investigators study the above parameter to realize the
physiological response to exercise of these patients and discover the appropriate exercise
intensity for prescription for EPB.
Status | Completed |
Enrollment | 600 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Dept of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital | Keelung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Bradley TD, Logan AG, Kimoff RJ, Sériès F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. — View Citation
Corrà U, Pistono M, Mezzani A, Braghiroli A, Giordano A, Lanfranchi P, Bosimini E, Gnemmi M, Giannuzzi P. Sleep and exertional periodic breathing in chronic heart failure: prognostic importance and interdependence. Circulation. 2006 Jan 3;113(1):44-50. Epub 2005 Dec 27. — View Citation
Francis DP, Davies LC, Piepoli M, Rauchhaus M, Ponikowski P, Coats AJ. Origin of oscillatory kinetics of respiratory gas exchange in chronic heart failure. Circulation. 1999 Sep 7;100(10):1065-70. — View Citation
Leite JJ, Mansur AJ, de Freitas HF, Chizola PR, Bocchi EA, Terra-Filho M, Neder JA, Lorenzi-Filho G. Periodic breathing during incremental exercise predicts mortality in patients with chronic heart failure evaluated for cardiac transplantation. J Am Coll Cardiol. 2003 Jun 18;41(12):2175-81. — View Citation
Yajima T, Koike A, Sugimoto K, Miyahara Y, Marumo F, Hiroe M. Mechanism of periodic breathing in patients with cardiovascular disease. Chest. 1994 Jul;106(1):142-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VO2 max(maximal oxygen consumption) | During cardiopulmonary exercise test, we could measure the value of patients' maximal oxygen consumption. It could represent the functional level of heart failure patient and be the mortality prediction. | 2 years | |
Secondary | EPB pattern | We define the exercise periodic breathing pattern in primary cardiopulmonary exercise test(CPET). After exercise intervention, we analyze the ventilation picture again in follow up CPET. (EPB also a morality prediction ) | 2 years | |
Secondary | All-cause mortality/CV morbidity | 2 years |
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