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

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

• Exercise limited by claudication, angina, neurological, pulmonary (FEV1 < 50%; FVC < 50%), or musculoskeletal disease.
• Active known malignancy; remission of < 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
• Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
• Any other non-cardiac condition that substantially decreases survival.
• Significant valvular stenosis or hypertrophic cardiomyopathy.
• Unable to comply with GH injection.
• Pregnancy or women of child bearing age not using adequate contraceptive means.
• Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
• Cor pulmonale.
• Acute myocarditis.
• Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
• Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH > 7 or < 0.2) at screening.
• Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
• Sustained ventricular tachycardia (lasting > 30 seconds) on screening Holter.
• 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.
• Failure to give informed consent