Long-Term Efficacy and Safety of Growth Hormone Replaceme... | NCT01576861

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

NCT01576861

Sponsor

Federico II University

Status

Completed

Last Update Posted

Oct 18, 2012Estimated

Enrollment

28Actual

Phase

Phase 2

Conditions

Growth Hormone Deficiency
Chronic Heart Failure

Interventions

Somatotropin

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 19, 2012

First Submission Date that Met QC Criteria

Apr 12, 2012

First Posted Date

Apr 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2012

Last Update Posted Date

Oct 18, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GH replacement	Experimental	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
Control CHF patients under optimized CHF therapy	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatotropin	Drug	Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day	GH replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Oxygen Consumption		after 48 months
Side effects		Any side effects recorded after 6,24 and 48 months

Secondary Outcomes

Measure	Description	Time Frame
Left Ventricular Ejection Fraction		after 48 months
Left Ventricular End-Systolic Volume		after 48 months
Left Ventricular End-Diastolic Volume

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine, Cardiovascular and Immunological Sciences		Naples	Campania	80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided