Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

October 14, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Increase of Left Ventricular Ejection Fraction [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
Maximal Oxygen Consumption [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Exercise Time on Cardiopulmonary testing [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
Increase in Insulin-like Growth Factor 1 [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency

Official Title ^ICMJE

Preliminary Study of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency

Brief Summary

Aim of this study is to define the possible benefits of growth hormone supplementation, in patients with heart failure due to left ventricular systolic dysfunction and coexisting growth hormone deficiency.

Detailed Description

A wide range of alterations in the GH/IGF-1 axis have been described to date 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 Unpublished experience of our group has led to the observation that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), as defined using current diagnostic criteria (GH stimulation test).

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

Since this was a preliminary study, no sample size calculation was applied, and changes 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Parallel Assignment

Condition ^ICMJE

Heart Failure
Growth Hormone Deficiency
Ischemic Heart Disease

Intervention ^ICMJE

Drug: Somatotropin

Study Arms / Comparison Groups

Experimental: Patients will receive 12 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
No Intervention: Optimal CHF treatment

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00591760

Responsible Party

Antonio Cittadini, Federico II University

Study ID Numbers ^ICMJE

GH replacement in HF

Study Sponsor ^ICMJE

Federico II University

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Federico II University

Verification Date

October 2008

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