Effects of Growth Hormone on Exercise Capacity - Full Text View

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00501514

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 III

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure

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 performace 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

University of Naples Federico II

More Information

Publications:

Fazio S, Sabatini D, Capaldo B, Vigorito C, Giordano A, Guida R, Pardo F, Biondi B, Sacca L. A preliminary study of growth hormone in the treatment of dilated cardiomyopathy. N Engl J Med. 1996 Mar 28;334(13):809-14.

Genth-Zotz S, Zotz R, Geil S, Voigtlander T, Meyer J, Darius H. Recombinant growth hormone therapy in patients with ischemic cardiomyopathy : effects on hemodynamics, left ventricular function, and cardiopulmonary exercise capacity. Circulation. 1999 Jan 5-12;99(1):18-21.

Osterziel KJ, Strohm O, Schuler J, Friedrich M, Hanlein D, Willenbrock R, Anker SD, Poole-Wilson PA, Ranke MB, Dietz R. Randomised, double-blind, placebo-controlled trial of human recombinant growth hormone in patients with chronic heart failure due to dilated cardiomyopathy. Lancet. 1998 Apr 25;351(9111):1233-7.

Study ID Numbers:	CTN 96-0870-001
Study First Received:	July 12, 2007
Last Updated:	July 12, 2007
ClinicalTrials.gov Identifier:	NCT00501514
Health Authority:	Italy: Ethics Committee

Keywords provided by Federico II University:

chronic heart failure
cardiopulmonary exercise
oxygen consumption
growth hormone

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009