Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460616
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2007-04-13
Brief Title:
Cardiac Valve Complications in Prolactinomas Treated With Cabergoline
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Observational Study to Investigate the Prevalence of Cardiac Abnormalities and Valvular Regurgitation in Patients With Prolactinomas Treated Chronically With Cabergoline
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ValveCab
Brief Summary:
Dopamine agonists are first-line agents for the treatment of prolactinomas 1 and Parkinsons disease 2 There is evidence supporting a causal relationship between the occurrence of drug-induced restrictive valvular heart disease and treatment with pergolide 3 in several cases the valvulopathy improved when pergolide was discontinued 4 Valvular heart damage has also been reported with the ergot-derived dopamine agonists bromocriptine and cabergoline 56
Two recent studies 78 have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinsons disease
The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents such as ergotamine and methysergide in the treatment of migraine or fenfluramine and dexfenfluramine in the treatment of obesity These abnormalities also closely resemble carcinoid-related valvulopathies 9
Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long 1 At variance with patients with Parkinsons disease patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower median bromocriptine dose 5 mgday and median cabergoline dose 1 mgweek Because of the young age of treatment beginning most patients with microprolactinomas start dopamine-agonist treatment in early adulthood treatment might be continued for over 3 decades the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown
To assess the prevalence of cardiac valve disease in patients treated with cabergoline we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively We wish to evaluate the severity of regurgitation for the mitral aortic and tricuspid valves Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose
Two recent studies 78 have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinsons disease
The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents such as ergotamine and methysergide in the treatment of migraine or fenfluramine and dexfenfluramine in the treatment of obesity These abnormalities also closely resemble carcinoid-related valvulopathies 9
Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long 1 At variance with patients with Parkinsons disease patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower median bromocriptine dose 5 mgday and median cabergoline dose 1 mgweek Because of the young age of treatment beginning most patients with microprolactinomas start dopamine-agonist treatment in early adulthood treatment might be continued for over 3 decades the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown
To assess the prevalence of cardiac valve disease in patients treated with cabergoline we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively We wish to evaluate the severity of regurgitation for the mitral aortic and tricuspid valves Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose
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 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 800 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 800-900 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
The endocrine profile will include measurement of IGF-I PRL FSH LH 17-β-estradiol testosterone FT3 FT4 TSH and cortisol at 800 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 800-900 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None