Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

This study has been completed.

Sponsor:

Information provided by:

Federico II University

ClinicalTrials.gov Identifier:

NCT00591760

First received: December 20, 2007

Last updated: October 17, 2012

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

October 17, 2012

Start Date ^ICMJE

December 2004

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak VO2 [ Time Frame: 6 months ]

changes in peak VO2

Original Primary Outcome Measures ^ICMJE

Increase of Left Ventricular Ejection Fraction [ Time Frame: 6 months, 12 months ]
Maximal Oxygen Consumption [ Time Frame: 6 months, 12 months ]

Change History

Complete list of historical versions of study NCT00591760 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Exercise Time on Cardiopulmonary testing [ Time Frame: 6 months, 12 months ]
Increase in Insulin-like Growth Factor 1 [ Time Frame: 6 Months, 12 Months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Official Title ^ICMJE

Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study

Brief Summary

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.

Detailed Description

To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure
Growth Hormone Deficiency
Ischemic Heart Disease

Intervention ^ICMJE

Drug: Somatotropin

Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Other Names:

rhGH
Saizen
NutropinAq

Study Arms

Experimental: GH
Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy

Intervention: Drug: Somatotropin
No Intervention: Placebo
PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

November 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Heart Failure in ew York Heart Association functional class II to IV
Left ventricular end diastolic diameter > 60 mm
Left ventricular ejection fraction < 40%
Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl)
Age 18-80 years
Clinical stability, guideline-oriented maximal pharmacological therapy
Informed consent

Exclusion Criteria:

Active Myocarditis
Hypertrophic Cardiomyopathy
Active endocarditis
Active malignancy
End stage renal disease
Severe liver disease (Child B-C)

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00591760

Other Study ID Numbers ^ICMJE

GH replacement in CHF

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Antonio Cittadini, Federico II University

Study Sponsor ^ICMJE

Federico II University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Antonio Cittadini, MD	Federico II University - Naples
Study Chair:	Luigi Saccà, MD	Federico II University

PRS Account

Federico II University

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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