Trials Sponsors Conditions Drugs Pricing

Conditions

Growth Hormone Deficiency Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (4)

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

Study Arms (2)

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

SomatotropinDrug

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

GH replacement

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
Age range 18-80 years

Sponsors & Collaborators

Federico II University
Otherlead

Study Sites (1)

Department of Internal Medicine, Cardiovascular and Immunological Sciences

Naples, Campania, 80131, Italy

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

March 19, 2012

First Posted

April 13, 2012

Study Start

January 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

GH replacement

Control CHF patients under optimized CHF therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (2)

GH replacement

Control CHF patients under optimized CHF therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations