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

This study has been completed.
Sponsor:
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00970463
First received: September 1, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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
Growth Hormone Deficiency
Cardiac Function

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Changes in cardiac function i relation to changes in the activity of the GH-axis [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
GH
Patients with GHD
Pegvisomant and Somatostatin analogues
Acromegaly

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mikkel Andreassen MD, Department of Endocrinology, Herlev Hospital, Herlev ringvej, 2730 Herlev, Denmark
ClinicalTrials.gov Identifier: NCT00970463     History of Changes
Other Study ID Numbers: KA-20060035
Study First Received: September 1, 2009
Last Updated: September 1, 2009
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
The GH-system and cardiac function

Additional relevant MeSH terms:
Acromegaly
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Dwarfism
Bone Diseases, Developmental
Hypopituitarism
Hormones
Natriuretic Peptide, Brain
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013