Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

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Brief Title

Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure


Brief Summary

      After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients
      With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the
      investigators wanted to collect data about the long-term efficacy and safety of this kind of
      therapy.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Peak Oxygen Consumption

Secondary Outcome

 Left Ventricular Ejection Fraction

Condition

Growth Hormone Deficiency

Intervention

Somatotropin

Study Arms / Comparison Groups

 GH replacement
Description:  Patients will receive 48 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

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

Drug

Estimated Enrollment

28

Start Date

January 2007

Completion Date

December 2011

Primary Completion Date

March 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Chronic Heart Failure New York Heart Association functional class II to IV, secondary
             to ischemic or idiopathic cardiomyopathy

          -  Age range 18-80 years

          -  Stable medication for at least one month including beta-blockers that had to be
             started at least 5 months before entering the study

          -  Left Ventricular ejection fraction 40% or less

          -  Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation
             with GHRH + Arginine < 9 ng/ml)

          -  Written Informed consent

        Exclusion Criteria:

          -  Acute proliferative or severe non-proliferative diabetic retinopathy

          -  Active malignancy

          -  Evidence of progression or recurrence of an underlying intracranial tumor

          -  Unstable Angina or recent myocardial infarction

          -  Serum Creatinine levels > 2.5 mg/dl

          -  Severe liver disease (Child-Pugh B-C)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01576861

Organization ID

Long-Term GH in CHF


Responsible Party

Principal Investigator

Study Sponsor

Federico II University


Study Sponsor

, , 


Verification Date

October 2012