Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF)

• Conditions: Chronic Heart Failure; Coronary Disease; Dilated Cardiomyopathy

• Registration Number: NCT01139086
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are

1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living

2. to compare endothelium function between CHF patients and healthy control subjects

3. the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Status Verified: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Last Update Submitted: 2010-06-07
• Study First Posted: 2010-06-08
• Last Update Posted: 2010-06-08
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Age 40-75 years
• Chronic heart failure: ejection fraction<40% and at stable condition
• Coronary Disease and dilated cardiomyopathy without heart failure
• Control group without diagnosis of any heart disease

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Exclusion Criteria

• Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
muscle strength and endurance	baseline	Measured by biodex

Secondary Outcome Measures

Name	Time	Method
skeletal muscle oxygenation response	baseline	Measured by near-infrared spectroscopy
Walking distance in 6-minute walking test	baseline	walking distance (m)
laser Doppler flowmetry combine iontophoresis	baseline	To measure the blood flux (PU) response to Ach (endothelial-dependent agent) and SNP (endothelial-independent agent)
sit-to-stand test	baseline	Measured times in 1 minute
questionnaire (functional activity and quality of life)	baseline
Analysis of venous blood sample	baseline	By standard venipuncture

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan