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

NCT ID: NCT00182169

Last Updated: 2005-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

2005-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Human recombinant growth hormone

Intervention Type DRUG

Eligibility Criteria

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 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Principal Investigators

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Catherine Demers, MD, MSc, FRCPC

Role: STUDY_DIRECTOR

McMaster University

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2004h00512

Identifier Type: -

Identifier Source: org_study_id