Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Failure Growth Hormone Deficiency Ischemic Heart Disease

Keywords

Heart FailureGrowth HormoneAnabolismAnabolic DeficiencyHormone replacement

Outcome Measures

Primary Outcomes (1)

Peak VO2
changes in peak VO2
6 months

Study Arms (2)

GH

EXPERIMENTAL

Patients will receive 6 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

Placebo

NO INTERVENTION

PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Interventions

SomatotropinDrug

Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Also known as: rhGH, Saizen, NutropinAq

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Heart Failure in ew York Heart Association functional class II to IV
Left ventricular end diastolic diameter \> 60 mm

Sponsors & Collaborators

Federico II University
Otherlead

MeSH Terms

Conditions

Heart FailureDwarfism, PituitaryMyocardial Ischemia

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary Diseases

Results Point of Contact

Title: Prof. Antonio Cittadini
Organization: Federico II University

Study Officials

Antonio Cittadini, MD
Federico II University - Naples
PRINCIPAL INVESTIGATOR
Luigi Saccà, MD
Federico II University
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

56 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

Study Record Dates

First Submitted

December 20, 2007

First Posted

January 11, 2008

Study Start

December 2004

Date type not reported

This date has not been verified as actual or estimated.

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

GH

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

GH

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record