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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01139086
• Other study ID #: 201003050R
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: June 7, 2010
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Ying-Tai Wu, Ph.D
• Phone: +886-2-33668129
• Email: ytw[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Chronic Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Dilated Cardiomyopathy
• Heart Failure

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength and endurance	Measured by biodex	baseline	No
Secondary	skeletal muscle oxygenation response	Measured by near-infrared spectroscopy	baseline	No
Secondary	Walking distance in 6-minute walking test	walking distance (m)	baseline	No
Secondary	laser Doppler flowmetry combine iontophoresis	To measure the blood flux (PU) response to Ach (endothelial-dependent agent) and SNP (endothelial-independent agent)	baseline	No
Secondary	sit-to-stand test	Measured times in 1 minute	baseline	No
Secondary	questionnaire (functional activity and quality of life)		baseline	No
Secondary	Analysis of venous blood sample	By standard venipuncture	baseline	No