Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure - Full Text View

Sponsor:	Hamilton Health Sciences Corporation
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00182169

Purpose

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

Condition	Intervention	Phase
Heart Failure	Drug: Human recombinant growth hormone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by McMaster University:

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

Estimated Enrollment:	80
Study Start Date:	July 1997
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182169

Locations

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8N3Z5

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

Study Director:

Catherine Demers, MD, MSc, FRCPC

McMaster University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00182169 History of Changes
Other Study ID Numbers:	2004h00512
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

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

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012