The Therapeutic Effect of Bromocriptin in Patients With Primary Aldosteronism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00451672
First received: March 22, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted

March 22, 2007
March 22, 2007
January 2007
Not Provided
tumor size, blood pressure
Same as current
No Changes Posted
serum potassium, aldosterone, renine
Same as current
Not Provided
Not Provided
 
The Therapeutic Effect of Bromocriptin in Patients With Primary Aldosteronism
Not Provided

we propose that bromocriptine may be an alternative treatment of primary aldosteronism, both APA and BAH.

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 hypertension(Corry 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 aldosterone/plasma 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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperaldosteronism
  • Hypertension
Drug: bromocriptine
Not Provided
Chang HW, Chu TS, Huang HY, Chueh SC, Wu VC, Chen YM, Hsieh BS, Wu KD. Down-Regulation of D2 Dopamine Receptor and Increased PKC{micro} Phosphorylation in Aldosterone-Producing Adenoma Play Roles in Aldosterone Overproduction. J Clin Endocrinol Metab. 2007 Feb 13; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
December 2007
Not Provided

Inclusion Criteria:

  • 20-60y/o hyperaldosteronsim patients

Exclusion Criteria:

  • Malignancy
  • Bed-ridden
  • Psychological disease
Both
20 Years to 60 Years
No
Contact: Kwan-Dun Wu, MD, PhD +886-2-23562082 walt-wu@yahoo.com.tw
Taiwan
 
NCT00451672
950912
No
Not Provided
National Taiwan University Hospital
Not Provided
Principal Investigator: Kwan-Dun Wu, MD, PhD Internal Medicine, Natinal Taiwan University Hospital
Study Director: Vin-Cent Wu, MD Internal Medicine, National Taiwan University Hospital
National Taiwan University Hospital
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP