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

Completed

• Conditions: Growth Hormone Deficiency; Cardiac Function

• Registration Number: NCT00970463
• Lead Sponsor: Herlev Hospital

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.

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 Timeline

• Study Start: 2006-01
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-09
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Last Update Submitted: 2009-09-01
• Study First Posted: 2009-09-02
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in cardiac function i relation to changes in the activity of the GH-axis