Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
N/AClinical Study ID
Ages > 20 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
IInclusion and exclusion criteria for study participation:
We will enroll subjects (males and females of all races) based on the inclusion/exclusion criteria described below. All subjects should be able to walk, sit and stand up indepedently. Screening procedures will be done prior to the study.
Inclusion criteria - CHF subjects:
Ability to walk, sit down and stand up independently
Age 45 years or older
Ability to lie in supine or elevated position for 9 hours
Diagnosis of CHF; under regular care by cardiologist
Reduced ejection fraction (<45%) assessed in the past 2 years
NYHA class II-IV
Clinically stable condition; no hospitalization 4 weeks preceding first study day
Willingness and ability to comply with the protocol
Inclusion criteria - COPD subjects:
Ability to walk, sit down and stand up independently
Age 45 years or older
Ability to lie in supine or elevated position for 8 hours
Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 < 70% of reference FEV1
Clinically stable condition and not suffering from a respiratory tract infection or exacerbation of their disease (defined as a combination of increased cough, sputum purulence, shortness of breath, systemic symptoms such as fever, and a decrease in FEV1 > 10% compared with values when clinically stable in the preceding year) at least 4 weeks prior to the first test day
Shortness of breath on exertion
Willingness and ability to comply with the protocol
Inclusion criteria - healthy subjects:
Healthy male & female according to the investigator's or appointed staff's judgment
Age 45 years and older, or 20 - 30 for healthy young group
Exclusion Criteria - all subjects:
Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (healthy subjects only)
Established diagnosis of malignancy
History of untreated metabolic diseases including hepatic or renal disorder
Presence of acute illness or metabolically unstable chronic illness
Presence of fever within the last 3 days
Body mass index >40 kg/m2 (healthy subjects only)
Any other condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient
Use of protein or amino acid containing nutritional supplements within 5 days prior first study day
Current Use of long-term oral corticosteroids (CHF only)
Use of short course of oral corticosteroids within 4 weeks preceding first study day
Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
(Possible) pregnancy
Already enrolled in another clinical trial and that clinical trial interferes with participating in this study
Study Design
Study Description
Connect with a study center
Texas A&M University
College Station, Texas 77843
United StatesSite Not Available
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