Clinical trial NCT00501514: Effects of Growth Hormone on Exercise Capacity
Official title: Effects of Growth Hormone on Exercise Capacity and Cardiopulmonary Performance in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
cardiopulmonary exercise
oxygen consumption
growth hormone
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2007-07-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.
timeFrame: three months
Secondary outcomes:
measure: Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.
timeFrame: three months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Dpt of internal medicine University Federico II
Study officials:
affiliation: Federico II University
name: Luigi Saccà, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fazio S, Sabatini D, Capaldo B, Vigorito C, Giordano A, Guida R, Pardo F, Biondi B, Sacca L. A preliminary study of growth hormone in the treatment of dilated cardiomyopathy. N Engl J Med. 1996 Mar 28;334(13):809-14. doi: 10.1056/NEJM199603283341301.
citation: Genth-Zotz S, Zotz R, Geil S, Voigtlander 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. doi: 10.1161/01.cir.99.1.18.
citation: Osterziel KJ, Strohm O, Schuler J, Friedrich M, Hanlein 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. doi: 10.1016/S0140-6736(97)11329-0.