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:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT00182169
Eligibility Criteria:
Inclusion Criteria:
Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of \< 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on "CHF" therapy at the time of randomization.
Exclusion Criteria:
1. Exercise limited by claudication, angina, neurological, pulmonary (FEV1 \< 50%; FVC \< 50%), or musculoskeletal disease.
2. Active known malignancy; remission of \< 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
3. Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
4. Any other non-cardiac condition that substantially decreases survival.
5. Significant valvular stenosis or hypertrophic cardiomyopathy.
6. Unable to comply with GH injection.
7. Pregnancy or women of child bearing age not using adequate contraceptive means.
8. Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
9. Cor pulmonale.
10. Acute myocarditis.
11. Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
12. Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH \> 7 or \< 0.2) at screening.
13. Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
14. Sustained ventricular tachycardia (lasting \> 30 seconds) on screening Holter.
15. Significant liver disease (INR\>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase \> 3X upper limit of normal; or bilirubin \> 2X the upper limit of normal) at baseline.
16. Failure to give informed consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00182169
Study Brief:
Protocol Section:
NCT00182169