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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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.


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