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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04033523
Other study ID # 201301077A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2013
Est. completion date July 1, 2016

Study information

Verified date July 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Consumptive coagulopathy is associated with increased mortality in patients with heart failure (HF). Physical activity influences the risk of major vascular thrombotic events. This study investigates how high-intensity interval training (HIIT) affects the capacity of endogenous thrombin generation (TG) by modulating circulatory procoagulant microparticles (MPs) in HF patients. Thirty-eight HF patients and 38 age- and gender-matched normal counterparts (NC) were recruited into this study. The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks, whereas the NC group did not receive any form of intervention. Plasma TG kinetics, procoagulant MPs, coagulation-related factors, and oxidative stress/proinflammatory status were analyzed. The results demonstrated that the HF group exhibited (i) less endogenous thrombin potential (ETP) and TG rate, (ii) lower concentration/activity of tissue factor (TF) and counts of TF-rich MPs derived from blood cells, and (iiii) higher vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations, compared to the NC group did. However, HIIT elevated plasma ETP and TG rate, as well as, TF concentration/activity and blood cell-derived procoagulant MP levels in the HF patients. Moreover, the exercise regimen also decreased vascular endothelial shedding and plasma myeloperoxidase and interleukin-6 concentrations in patients with HF. Hence, we conclude that HF reduces the capacity of endogenous TG in plasma, which is associated with decreased (or consumed) circulatory procoagulant MP levels. However, HIIT alleviates HF-declined endogenous TG capacity and vascular endothelial damage through recuperating TF-related coagulation activity and suppressing oxidative stress/proinflammatory status.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date July 1, 2016
Est. primary completion date July 1, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- The HF was diagnosed if the patients had a left ventricular ejection fraction (LVEF) <40%.

- All HF patients were New York Heart Association (NYHA) functional class II or III and had received optimal treatment for at least 12 months according to American Heart Association/American College of Cardiology guidelines.

Exclusion Criteria:

- Patients with the presence of atrial fibrillation/flutter, second/third degree heart block, history of life-threatening ventricular arrhythmias, recent unstable angina, myocardial infarction or coronary revascularization (<4 weeks), uncontrolled diabetes mellitus, severe chronic obstructive pulmonary disease, or symptomatic cerebral vascular disease within 12 months, collagen vascular disease, alcohol or drug abuse during the previous 12 months or significant renal or hepatic disease were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HIIT
The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Thrombin generation assay PPP was measure the rate of thrombin generation using the calibrated automated thrombogram (CAT) assay (Synapse/Thrombinoscope BV). 12 weeks
Primary Microparticles derived from blood cells and shedding endothelial cells Platelet-poor plasma (PPP) was separated from whole blood by centrifugation at 1,600g for 10 min at room temperature.
The quantification of microparticles in PPP was determined by a three-color FACScan flow cytometer.
12 weeks
Secondary Cardiopulmonary fitness evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system 12 weeks
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