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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00460616 |
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Date of registration:
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13/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
ValveCab |
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Scientific title:
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Observational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With Cabergoline |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00460616 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Annamaria AL Colao, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federico II University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with documented hyperprolactinemia receiving continuous treatment with
cabergoline only for at least 12 months
- Newly diagnosed patients with prolactinoma never previously receiving dopamine
agonists treatment
Exclusion Criteria:
- A history of cardiac valve abnormalities,
- Previous use of anorectic drugs or other ergot-derived drugs,
- Treatment with cabergoline for less than 12 months,
- Valve calcification, valve regurgitation associated with annular dilatation or
excessive leaflet motion,
- Mitral regurgitation associated with left ventricular wall-motion abnormalities or
left ventricular dilatation,
- Withdrawal from cabergoline treatment for longer than 1 month, according with our
treatment protocol (11).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prolactinomas
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Intervention(s)
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Drug: Cabergoline
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Primary Outcome(s)
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Prevalence of regurgitation (graded as mild, moderate, severe) at any cardiac valve.
[Time Frame: 9 months]
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Secondary ID(s)
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NeuroendoUnit-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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