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Effects of Growth Hormone on Exercise Capacity

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Growth hormone

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, cardiopulmonary exercise, oxygen consumption, growth hormone

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Dpt of internal medicine University Federico II

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00501514

First Posted

July 12, 2007

Last Updated

January 28, 2009

Sponsor

Federico II University

1. Study Identification

Unique Protocol Identification Number

NCT00501514

Brief Title

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

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

November 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federico II University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Growth hormone

Primary Outcome Measure Information:

Title

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

Time Frame

three months

Secondary Outcome Measure Information:

Title

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

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luigi Saccà, MD

Organizational Affiliation

Federico II University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dpt of internal medicine University Federico II

City

Naples

ZIP/Postal Code

80131

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

8596546

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.

Results Reference

background

PubMed Identifier

9884373

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.

Results Reference

background

PubMed Identifier

9643742

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.

Results Reference

background

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Effects of Growth Hormone on Exercise Capacity

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