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

NCT ID: NCT00970463

Last Updated: 2009-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Growth Hormone Deficiency Cardiac Function

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GH

Patients with GHD

No interventions assigned to this group

Pegvisomant and Somatostatin analogues

Acromegaly

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Endocrinology, Herlev Hospital, Herlev ringvej, 2730 Herlev, Denmark

References

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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.

Reference Type DERIVED
PMID: 20730514 (View on PubMed)

Other Identifiers

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KA-20060035

Identifier Type: -

Identifier Source: org_study_id

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