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

NCT00182169 | Completed Phase 2

• 1 other identifier: 2004h00512
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 6 months on exercise capacity, heart function and quality of life

Conditions

Heart Failure

Keywords

Severe heart failure; Growth hormone; exercise capacity; quality of life; cardiac function

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy

Secondary Outcomes (5)

• Cardiac Function measured with radionuclide angiography and echocardiography

• Exercise capacity measured during treadmill testing (duration of exercise)

• Quality of life measured with Minnesota Living with Heart Failure

• Neurohormones

• baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy

Interventions

Human recombinant growth hormone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Catherine Demers, MD, MSc, FRCPC

  McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 1997
• Study Completion: June 1, 2005
• Last Updated: September 16, 2005

Record last verified: 2003-03

Locations

CA (1)