Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
Keywords
Abstract
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 electrocardiogram and an echocardiogram.
The endocrine profile will include measurement of IGF-I, PRL, FSH, LH, 17-β-estradiol, testosterone, FT3, FT4, TSH, and cortisol at 8.00 in the morning after an overnight fasting.
The clinical profile will include blood pressure measurement at the right arm, with the subjects in relaxed sitting position. The average of six measurements (three taken by each of two examiners, in the same day of echocardiography, between 8.00-9.00 in the morning) with a mercury sphygmomanometer will be used in all analysis. According with the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (10), hypertension, if present, is classified as mild (Stage 1) when the SBP or DBP were between 140 and 159 mmHg and between 90 and 99 mmHg, respectively; severe (Stage 2) when the SBP or DBP were >160 and >100 mmHg respectively; pre-hypertension is defined as SBP >120¬ and <140 and DBP >80 and <90 mmHg. Heart rate will be also measured.
Dates
Last Verified: | 09/30/2007 |
First Submitted: | 04/12/2007 |
Estimated Enrollment Submitted: | 04/12/2007 |
First Posted: | 04/15/2007 |
Last Update Submitted: | 04/13/2008 |
Last Update Posted: | 04/15/2008 |
Actual Study Start Date: | 12/31/2006 |
Estimated Study Completion Date: | 08/31/2007 |
Condition or disease
Intervention/treatment
Drug: 1
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
1 Patients already receiving treatment with cabergoline. | Drug: 1 According with our previous studies, in the patients with microprolactinoma and in those with non-tumoral hyperprolactinemia, cabergoline treatment was administered orally at a starting dose of 0.25 mg twice weekly for the first two weeks and then 0.5 mg twice weekly. After 2 months of treatment, dose adjustment was carried out every 2 months on the basis of serum PRL suppression. |
2 healthy controls sex and age-matched with the patients |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | 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). |
Outcome
Primary Outcome Measures
1. Prevalence of regurgitation (graded as mild, moderate, severe) at any cardiac valve. [9 months]