We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00970463
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:

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
Growth Hormone Deficiency Cardiac Function

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 : January 2006
Primary Completion Date : May 2009
Study Completion Date : May 2009


Groups and Cohorts

Group/Cohort
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
More Information

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
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: September 2, 2009
Last Verified: September 2009

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

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Acromegaly
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hyperpituitarism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs