ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure

This study has been completed.

Sponsored by: Hamilton Health Sciences
Information provided by: Hamilton Health Sciences
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

MedlinePlus related topics:   Exercise and Physical Fitness    Heart Failure   

ChemIDplus related topics:   Somatotropin    Somatropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Hamilton Health Sciences:

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:

  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
  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

Investigators
Study Director:     Catherine Demers, MD, MSc, FRCPC     Hamilton Health Sciences    
  More Information

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

Keywords provided by Hamilton Health Sciences:
Severe heart failure  
Growth hormone  
exercise capacity  
quality of life  
cardiac function  

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Quality of Life

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




Links to all studies - primarily for crawlers