Growth Hormone DeficiencyNCT00970463
Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly
An observational study of Growth Hormone Deficiency and Cardiac Function, run by Herlev Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Growth Hormone Deficiency, Cardiac Function
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Contraindications for magnetic resonance scan
About this study
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
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.
Read the 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.
- Conditions
- Growth Hormone Deficiency, Cardiac Function
- Keywords
- The GH-system and cardiac function
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GH | Patients with GHD | |
| Pegvisomant and Somatostatin analogues | Acromegaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac function i relation to changes in the activity of the GH-axis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970463
- Sponsor's protocol ID
- KA-20060035
- Status last verified
- Sep 2009
- First submitted
- 1 Sep 2009
- Last updated
- 2 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20730514
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00970463
- Acronym / sponsor ID
- KA-20060035
- Conditions
- Growth Hormone Deficiency, Cardiac Function
- Keywords
- The GH-system and cardiac function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH | – | –Patients with GHD |
| Pegvisomant and Somatostatin analogues | – | –Acromegaly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications for magnetic resonance scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in cardiac function i relation to changes in the activity of the GH-axis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2009.
- Derived from this study: PubMed 20730514Andreassen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Cardiac Function, run by Herlev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiac function i relation to changes in the activity of the GH-axis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2009.