NCT00501514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

July 12, 2007

Last Update Submit

January 28, 2009

Conditions

Chronic Heart Failure

Keywords

chronic heart failurecardiopulmonary exerciseoxygen consumptiongrowth hormone

Outcome Measures

Primary Outcomes (1)

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

    three months

Secondary Outcomes (1)

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

    three months

Interventions

Growth hormoneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ejection fraction \< 40%
  • Left ventricular internal dimension \>58 mm
  • II-III NYHA class
  • Stable hemodynamic condition during the previous three months
  • Sinus rhythm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of internal medicine University Federico II

Naples, 80131, Italy

Location

Related Publications (3)

  • 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.

    PMID: 8596546BACKGROUND

  • 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.

    PMID: 9884373BACKGROUND

  • 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.

    PMID: 9643742BACKGROUND

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Luigi Saccà, MD

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 16, 2007

Study Start

November 1, 1997

Study Completion

November 1, 2005

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

IT(1)