Effects of Growth Hormone on Exercise Capacity

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501514

Enrollment

Registered

2007-07-16

Start date

1997-11-30

Completion date

2005-11-30

Last updated

2009-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

chronic heart failure, cardiopulmonary exercise, oxygen consumption, growth hormone

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.

Interventions

DRUGGrowth hormone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.	three months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026