Status:
COMPLETED
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.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
Key Trial Info
Start Date :
July 1 1997
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00182169
Start Date
July 1 1997
End Date
June 1 2005
Last Update
September 16 2005
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8N3Z5