Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501514
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2007-07-12
Brief Title:
Effects of Growth Hormone on Exercise Capacity
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to assess whether Growth HormoneGHimproves 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 CHFConsequently 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 CHFThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None