Effects of Growth Hormone on Exercise Capacity

Federico II University

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Drug: Growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT00501514

CTN 96-0870-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind