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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01139086
First received: June 7, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.

Condition
Chronic Heart Failure
Coronary Disease
Dilated Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • muscle strength and endurance [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Measured by biodex


Secondary Outcome Measures:
  • skeletal muscle oxygenation response [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Measured by near-infrared spectroscopy

  • Walking distance in 6-minute walking test [ Time Frame: baseline ] [ Designated as safety issue: No ]
    walking distance (m)

  • laser Doppler flowmetry combine iontophoresis [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To measure the blood flux (PU) response to Ach (endothelial-dependent agent) and SNP (endothelial-independent agent)

  • sit-to-stand test [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Measured times in 1 minute

  • questionnaire (functional activity and quality of life) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Analysis of venous blood sample [ Time Frame: baseline ] [ Designated as safety issue: No ]
    By standard venipuncture


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139086

Contacts
Contact: Ying-Tai Wu, Ph.D +886-2-33668129 ytw@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 100
Contact: Ying-Tai Wu, Ph. D     886-2-33668129     ytw@ntu.edu.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ying-Tai Wu, Ph.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ying-Tai Wu, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT01139086     History of Changes
Other Study ID Numbers: 201003050R
Study First Received: June 7, 2010
Last Updated: June 7, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
chronic heart failure
isokinetic test
near-infrared spectroscopy
laser Doppler flowmetry
endothelial function

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Coronary Disease
Coronary Artery Disease
Heart Failure
Cardiomyopathies
Cardiomegaly
 Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on June 18, 2013