Effects of Growth Hormone on Exercise Capacity

Chronic Heart Failure Clinical Trial

Official title:

Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501514
• Other study ID #: CTN 96-0870-001
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2007
• Last updated: January 28, 2009
• Start date: November 1997
• Est. completion date: November 2005

Study information

• Verified date: January 2009
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Growth hormone

Locations

Country	Name	City	State
Italy	Dpt of internal medicine University Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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

Genth-Zotz S, Zotz R, Geil S, Voigtländer 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. — View Citation

Osterziel KJ, Strohm O, Schuler J, Friedrich M, Hänlein 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.		three months
Secondary	Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.		three months