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NCT00970463 Clinical Trial

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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00970463
Other study ID # KA-20060035
Secondary ID
Status Completed
Phase N/A
First received September 1, 2009
Last updated September 1, 2009
Start date January 2006
Est. completion date May 2009

Study information
Verified date September 2009
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in cardiac function i relation to changes in the activity of the GH-axis No
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