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Effects of Growth Hormone on Exercise Capacity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501514
First Posted: July 16, 2007
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federico II University
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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