NCT01139086

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. 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. 2.to compare endothelium function between CHF patients and healthy control subjects
  3. 3.the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

June 7, 2010

Last Update Submit

June 7, 2010

Conditions

Keywords

chronic heart failureisokinetic testnear-infrared spectroscopylaser Doppler flowmetryendothelial function

Outcome Measures

Primary Outcomes (1)

  • muscle strength and endurance

    Measured by biodex

    baseline

Secondary Outcomes (6)

  • skeletal muscle oxygenation response

    baseline

  • Walking distance in 6-minute walking test

    baseline

  • laser Doppler flowmetry combine iontophoresis

    baseline

  • sit-to-stand test

    baseline

  • questionnaire (functional activity and quality of life)

    baseline

  • +1 more secondary outcomes

Study Arms (3)

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 Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseCardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ying-Tai Wu, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying-Tai Wu, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 8, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations