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Completed

NCT Number: NCT00501514

Effects of Growth Hormone on Exercise Capacity

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

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Key information

Conditions

Chronic Heart Failure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dpt of internal medicine University Federico II

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

Primary outcomes

  1. The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing.

    Time frame: three months

Secondary outcomes

  1. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
1997
Study completion
2005
First posted
Jul 16, 2007
Registry last updated
Jan 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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