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Effects of Growth Hormone on Exercise Capacity

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00501514
First received: July 12, 2007
Last updated: January 28, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.


Condition Intervention Phase
Chronic Heart Failure
 Drug: Growth hormone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. [ Time Frame: three months ]

Secondary Outcome Measures:
  • Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography. [ Time Frame: three months ]

Enrollment: 22
Study Start Date: November 1997
Study Completion Date: November 2005
Detailed Description:

clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ejection fraction < 40%
  • Left ventricular internal dimension >58 mm
  • II-III NYHA class
  • Stable hemodynamic condition during the previous three months
  • Sinus rhythm

Exclusion Criteria:

  • IMA or CABG or PTCA in the previous six months
  • Instable angina
  • Major arrhythmias (Lown class> IV)
  • Diseases limiting exercise capacity
  • Insulin treated diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501514

Locations
Italy
Dpt of internal medicine University Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Luigi Saccà, MD Federico II University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00501514     History of Changes
Other Study ID Numbers: CTN 96-0870-001
Study First Received: July 12, 2007
Last Updated: January 28, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
chronic heart failure
cardiopulmonary exercise
oxygen consumption
growth hormone

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 May 23, 2013