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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Human recombinant growth hormone
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Severe heart failure, Growth hormone, exercise capacity, quality of life, cardiac function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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: 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 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.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

Sites / Locations

  • McMaster University

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00182169
Brief Title
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure
Official Title
Randomized, Placebo Control, Clinical Trial Evaluating the Effect of Human Recombinant Growth Hormone in Patients With Severe Congestive Heart Failure. The Growth Hormone In Heart Failure Trial (GIFT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Severe heart failure, Growth hormone, exercise capacity, quality of life, cardiac function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Human recombinant growth hormone
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Cardiac Function measured with radionuclide angiography and echocardiography
Title
Exercise capacity measured during treadmill testing (duration of exercise)
Title
Quality of life measured with Minnesota Living with Heart Failure
Title
Neurohormones
Title
baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Demers, MD, MSc, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada

12. IPD Sharing Statement

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

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