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

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT01576861

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency Chronic Heart Failure	Drug: Somatotropin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GH replacement 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	Drug: Somatotropin Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
No Intervention: Control CHF patients under optimized CHF therapy

Arm

Intervention/Treatment

Experimental: GH replacement

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

Drug: Somatotropin

Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day

No Intervention: Control CHF patients under optimized CHF therapy

Outcome Measures

Primary Outcome Measures

Peak Oxygen Consumption [after 48 months]
Side effects [Any side effects recorded after 6,24 and 48 months]

Secondary Outcome Measures

Left Ventricular Ejection Fraction [after 48 months]
Left Ventricular End-Systolic Volume [after 48 months]
Left Ventricular End-Diastolic Volume [after 48 months]
Quality of Life [after 48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine, Cardiovascular and Immunological Sciences	Napoli	Campania	Italy	80131

Sponsors and Collaborators

Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Cittadini, Associate Professor, Federico II University

ClinicalTrials.gov Identifier:

NCT01576861

Other Study ID Numbers:

Long-Term GH in CHF

First Posted:

Apr 13, 2012

Last Update Posted:

Oct 18, 2012

Last Verified:

Oct 1, 2012

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Oct 18, 2012