Trial Information

Observational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With Cabergoline

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.