Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00064727
Eligibility Criteria:
* INCLUSION CRITERIA:
Adult normal volunteers, age matched (55-75 years of age)
Adult patients greater than 21 years of age who meet the following criteria:
* Heart Failure due to ischemic heart disease or of idiopathic etiology
* Depressed LV systolic function, EF less than or equal to 0.45 by Radionuclide Angiography (MUGA)
* New York Heart Association Functional Class II or III
* Patient stable on current heart failure therapy
* Evidence of insulin resistance or type II diabetes on insulin-sensitivity screening
* No predicted cardiac revascularization therapy requirements
EXCLUSION CRITERIA:
Pregnant or lactating
History of admission for acute heart failure exacerbation within last one month
Acute myocardial infarction within the last three months
Cardiac resynchronization pacemaker placement within the last three months
Genetic defect known to have induced heart failure
Serum creatinine greater than 2.5 mg/dL.
Liver transaminase levels greater than 2.5 x upper limit of normal
Requirement for insulin therapy to control blood glucose
Current use of thiazolidinedione for diabetic control or history of discontinuation of thiazolidinedione therapy following development of side effects
Uncontrolled blood glucose levels or the use of insulin therapy to control diabetes
Immune compromise including chronic HIV, HBV, and HCV infection
Chronic systemic inflammatory disease such as SLE, rheumatoid arthritis, collagen vascular disease
Participation in unrelated research involving investigational pharmacological agent 30 days before planned dosing
Current alcohol or drug abuse
Inability to provide informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT00064727
Study Brief:
Protocol Section:
NCT00064727