NCT00511927

Brief Summary

Aim of this study is to define the possible detrimental effect of a lack of growth hormone, on the well-being and life expectation of patients affected by heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

3.6 years

First QC Date

August 3, 2007

Last Update Submit

February 18, 2014

Conditions

Ischemic Heart DiseaseCardiomyopathyHeart FailureGrowth Hormone Deficiency

Keywords

heartfailuregrowthhormoneigfdilativecardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Study Arms (2)

GHD

Patients with Growth Hormone Deficiency

non-GHD

Patients with CHF, without coexisting growth hormone deficiency

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic heart failure due to left ventricular systolic dysfunction

You may qualify if:

  • Diagnosis of Heart Failure: NYHA class II to IV, ACC/AHA stage C/D
  • Left ventricular end diastolic diameter \>60 mm
  • Left ventricular ejection fraction \< 40%
  • Clinical stability, guideline-oriented top pharmacological therapy
  • Informed consent

You may not qualify if:

  • Active Myocarditis
  • Hypertrophic Cardiomyopathy
  • Active endocarditis
  • Active malignancy
  • End stage renal disease
  • Severe liver disease (Child B-C)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

III Medicina Interna - Federico II University

Naples, 80100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera of the patients at time-points upon recruitment and after 12 months

MeSH Terms

Conditions

Myocardial IschemiaCardiomyopathiesHeart FailureDwarfism, Pituitary

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Antonio Cittadini, MD

    Federico II University

    STUDY DIRECTOR

  • Luigi Saccà, MD

    Federico II University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Study Start

July 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

IT(1)