Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure

Hamilton Health Sciences (HHS)

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Human recombinant growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT00182169

2004h00512

Details and patient eligibility

About

Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind