NCT00970463

Brief Summary

To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

3.3 years

First QC Date

September 1, 2009

Last Update Submit

September 1, 2009

Conditions

Growth Hormone DeficiencyCardiac Function

Keywords

The GH-system and cardiac function

Outcome Measures

Primary Outcomes (1)

  • Changes in cardiac function i relation to changes in the activity of the GH-axis

Study Arms (2)

GH

Patients with GHD

Pegvisomant and Somatostatin analogues

Acromegaly

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with GHD based on an insufficient stimulation of GH-secretion during Pyridostigmin-GHRH test. Patients with acromegaly based on an insufficient supression of GH-secretion during oral glucose tolerance test

You may qualify if:

  • Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test.
  • Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test

You may not qualify if:

  • Contraindications for magnetic resonance scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andreassen M, Faber J, Kjaer A, Petersen CL, Kristensen LO. Cardiac function in growth hormone deficient patients before and after 1 year with replacement therapy: a magnetic resonance imaging study. Pituitary. 2011 Mar;14(1):1-10. doi: 10.1007/s11102-010-0250-7.

    PMID: 20730514DERIVED

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 2, 2009

Record last verified: 2009-09