High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033523
• Other study ID #: 201301077A3
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Heart Failure
• High-intensity Interval Training

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