Effects of Growth Hormone on Exercise Capacity

Phase 3

Completed

• Conditions: Chronic Heart Failure

• Registration Number: NCT00501514
• Lead Sponsor: Federico II University

Brief 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.

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.

Study Timeline

• Study Start: 1997-11
• Study Completion: 2005-11
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-16
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-28
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.	three months

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.	three months

Trial Locations

Locations (1)

Dpt of internal medicine University Federico II; 🇮🇹 Naples, Italy