Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451672
Status:
UNKNOWN
Last Update Posted:
2007-03-23
First Post:
2007-03-22
Brief Title:
The Therapeutic Effect of Bromocriptin in Patients With Primary Aldosteronism
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
we propose that bromocriptine may be an alternative treatment of primary aldosteronism both APA and BAH
Detailed Description:
Primary aldosteronism PA a common curable disease of hypertension is characterized by inappropriate production of aldosterone which is at least partially autonomous of the renin-angiotensin system A recent clinical study reported that patients with PA experience a higher sate of a higher rate of cardiovascular events than those with essential hypertensionCorry and Tuck 2003 Milliez Girerd et al 2005 The prevalence of metabolic syndrome was higher in primary aldosteronism than in essential hypertension was also reported Fallo Veglio et al 2006 The wide applying of the plasma aldosteroneplasma rennin activity ARR as a screening test among hypertensive patients have reported a much higher prevalence of this disease up to 12 of hypertensive patients In the past decade an increase in diagnosis rate of PA has been observed in National Taiwan University Hospital with an average of 15-20 newly diagnosis cases every year
Idiopathic bilateral adrenal hyperplasia BAH and aldosterone-producing adenoma APA are the leading causes of primary aldosteronism Unilateral adrenalectomy is the reasonable therapeutic option of APA and aldosterone antagonists usually brings about well blood pressure BP control in BAH Not every APA patient would accept operation because of other medical conditions or the cure rate of hypertension in APA after adrenalectomy is 50-70 in most studies For patients with BAH aldosterone antagonists are the first choice of treatment however intolerance to high dose of these medications is not uncommon To our best knowledge there is no alternative treatment for these patients
Dopaminergic regulation of aldosterone secretion has been well demonstrated in normal subjects as well as patients with PA We have shown that D2 receptor can down-regulate the transcription of aldosterone synthase CYP11B2 via a specific PKC isoform and probably intracellular calcium level Furthermore there is a reciprocal change of the mRNA of D2 receptor and CYP11B2 in APA D2 receptor has also been demonstrated in other neuroendocrine tumors eg pheochromocytoma prolactinoma GH-secreting adenoma ect Camacho Mazzone 1999 Administration of D2 agonist bromocriptin BMC is a standard treatment of prolactinoma either for pre-operative reduction of the tumors or for non-surgical patients Chattopadhyay et al 2005 Reduction or shrinkage of prolactinoma has been observed in patients treated with BMC Biswas et al 2005 Anti-proliferative effect and apoptosis of BMC have been demonstrated in several cell lines Wasko et al 2004 Recently we also demonstrated that BMC in addition to decrease aldosterone secretion and expression of CYP11B2 could inhibit cell proliferation of H295 cells an adrenocortical carcinoma cell line with a down-regulation of ERK In this context we propose that BMC may be an alternative treatment of PA both APA and BAH
Idiopathic bilateral adrenal hyperplasia BAH and aldosterone-producing adenoma APA are the leading causes of primary aldosteronism Unilateral adrenalectomy is the reasonable therapeutic option of APA and aldosterone antagonists usually brings about well blood pressure BP control in BAH Not every APA patient would accept operation because of other medical conditions or the cure rate of hypertension in APA after adrenalectomy is 50-70 in most studies For patients with BAH aldosterone antagonists are the first choice of treatment however intolerance to high dose of these medications is not uncommon To our best knowledge there is no alternative treatment for these patients
Dopaminergic regulation of aldosterone secretion has been well demonstrated in normal subjects as well as patients with PA We have shown that D2 receptor can down-regulate the transcription of aldosterone synthase CYP11B2 via a specific PKC isoform and probably intracellular calcium level Furthermore there is a reciprocal change of the mRNA of D2 receptor and CYP11B2 in APA D2 receptor has also been demonstrated in other neuroendocrine tumors eg pheochromocytoma prolactinoma GH-secreting adenoma ect Camacho Mazzone 1999 Administration of D2 agonist bromocriptin BMC is a standard treatment of prolactinoma either for pre-operative reduction of the tumors or for non-surgical patients Chattopadhyay et al 2005 Reduction or shrinkage of prolactinoma has been observed in patients treated with BMC Biswas et al 2005 Anti-proliferative effect and apoptosis of BMC have been demonstrated in several cell lines Wasko et al 2004 Recently we also demonstrated that BMC in addition to decrease aldosterone secretion and expression of CYP11B2 could inhibit cell proliferation of H295 cells an adrenocortical carcinoma cell line with a down-regulation of ERK In this context we propose that BMC may be an alternative treatment of PA both APA and BAH
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