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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ying-Tai Wu, Ph. D; Phone Number: 886-2-33668129; Email: ytw@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Chronic Heart Failure Coronary Disease Dilated Cardiomyopathy Control group without diagnosis of any heart disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cardiovascular disease; Diagnosis of cardiomyopathy or ischemic heart disease without heart failure
Chronic heart failure; Diagnosis of cardiomyopathy or ischemic heart disease LVEF <40%
Control; Age and body built matched with chronic heart failure group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength and endurance	Measured by biodex	baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2011
• Study Completion (ANTICIPATED): May 1, 2011

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (ESTIMATE): June 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2010
• Last Update Submitted That Met QC Criteria: June 7, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: near-infrared spectroscopy; endothelial function; laser Doppler flowmetry; chronic heart failure; isokinetic test
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Coronary Disease; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 201003050R