Status:
COMPLETED
Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
Lead Sponsor:
Federico II University
Conditions:
Prolactinomas
Eligibility:
All Genders
18-65 years
Brief Summary
Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "r...
Detailed Description
Within one week from a clinical observation in the outpatient service, all patients will be admitted to the hospital for a complete endocrine screening, a cardiological visit that will include an elec...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00460616
Start Date
January 1 2007
End Date
September 1 2007
Last Update
April 16 2008
Active Locations (1)
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1
Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples
Via S. Pansini 5 Naples, Italy, 80131