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Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00970463
Collaborator
(none)
22
Enrollment
40
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment modalities.

    Patients will be examined by Cardiac MRI before treatment and after one year of treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Growth Hormone on Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) and on Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
    Study Start Date :
    Jan 1, 2006
    Actual Primary Completion Date :
    May 1, 2009
    Actual Study Completion Date :
    May 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    GH

    Patients with GHD
    Pegvisomant and Somatostatin analogues

    Acromegaly

    Outcome Measures

    Primary Outcome Measures

    1. Changes in cardiac function i relation to changes in the activity of the GH-axis []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • Contraindications for magnetic resonance scan

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00970463
    Other Study ID Numbers:
    • KA-20060035
    First Posted:
    Sep 2, 2009
    Last Update Posted:
    Sep 2, 2009
    Last Verified:
    Sep 1, 2009
    Keywords provided by , ,
    The GH-system and cardiac function
    Additional relevant MeSH terms:
    Dwarfism, Pituitary
    Acromegaly
    Endocrine System Diseases

    Study Results

    No Results Posted as of Sep 2, 2009