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

Results First Received: March 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Conditions:	Heart Failure Growth Hormone Deficiency Ischemic Heart Disease
Intervention:	Drug: Somatotropin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Sixty-three patients with CHF NYHA class II-IV and GH deficiency were enrolled from December 2004 to December 2006. These patients were consecutively selected from a cohort of 158 ambulatory patients referred to our tertiary care center and, to a minor extent, patients hospitalized for CHF.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients recruited during hospital stay were studied after a 3-months period of optimized medical therapy and clinical stability

Reporting Groups

	Description
GH Replacement Therapy	Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
Control	Optimal CHF treatment

Participant Flow: Overall Study

	GH Replacement Therapy	Control
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
GH Replacement Therapy	Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
Control	Optimal CHF treatment
Total	Total of all reporting groups

Baseline Measures

	GH Replacement Therapy	Control	Total
Number of Participants [units: participants]	28	28	56
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	15	17	32
>=65 years	13	11	24
Age [units: years] Mean ± Standard Deviation	62 ± 6	62 ± 8	62 ± 4
Gender [units: participants]
Female	4	5	9
Male	24	23	47
echocardiography [units: % of ejection fraction] Mean ( Full Range )	30 ( 20 to 70 )	40 ( 20 to 70 )	35 ( 20 to 70 )

Outcome Measures

1. Primary:

Peak VO2 [ Time Frame: 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Prof. Antonio Cittadini
Organization: Federico II University
phone: 0039(0)817464375
e-mail: antonio.cittadini@unina.it

No publications provided

Responsible Party:	Antonio Cittadini, Federico II University
ClinicalTrials.gov Identifier:	NCT00591760 History of Changes
Other Study ID Numbers:	GH replacement in CHF
Study First Received:	December 20, 2007
Results First Received:	March 23, 2009
Last Updated:	October 17, 2012
Health Authority:	Italy: Ethics Committee Italy: Ministry of Health

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