Postoperative Cardiovascular Index Change of Primary Aldosteronism

Aldosteronism Clinical Trial

— TAIPAI  

Official title:

Postoperative Cardiovascular Index Change of Primary Aldosteronism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00746070
• Other study ID #: 200611031R
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 1, 2008
• Last updated: May 3, 2010
• Start date: January 2007
• Est. completion date: January 2013

Study information

• Verified date: April 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

Primary aldosteronism (PA), characterized by an inappropriate production of aldosterone, is far more common than is usually perceived. The overall prevalence of PA is 11.2% of the newly diagnosed hypertensive patients and 4.8% was curable aldosterone producing adenoma (APA), and adrenalectomy is considered the treatment of choice for APA. The potential curability and prevention of excess cardiovascular damage and events also underscores the need to develop accurate strategies for the timely diagnosis of APA.This study aimed to determine the effects of endothelium function change ( PWV, progenitor cell,..) before and post-adrenalectomy or taking spironolactone in patients with aldosteronism. Autonomous elevated aldosterone will increase the glomerular filtration rate and renal damage in patients with primary aldosteronism (PA). But clinical evidence of the role of endothelium function on post-adrenalectomy or taking spirolactone is still limited.

Description:

Aldosterone has rapid nongenomic effects in the human vasculature. Aldosterone has been claimed to lead to endothelial dysfunction, a condition related to development of cardiovascular disorders and to poor prognosis. However, studies of aldosterone effects on endothelial function led to discrepant findings, which may be related, at least in part, to inhomogeneity of the populations studied. Thus, studies in healthy subjects showed no detrimental effects of aldosterone on endothelial function and no positive effect of aldosterone inhibition, whereas populations with established cardiovascular diseases showed negative effects of aldosterone and positive effects of spironolactone therapy. Still, other factors may be of importance as effects of aldosterone on endothelial function are not homogenous even in a healthy population. Dosages of aldosterone, concomitant drug use, as well as the vascular bed investigated may influence the effects observed.

Furthermore, little is known about chronic endothelial effects of aldosterone that could indicate a primary and direct role of aldosterone in development of cardiovascular diseases. In patients with hyperaldosteronism diminished flow-mediated dilation was found, indicating impaired endothelial function compared with hypertensive patients without elevated aldosterone. However, it is not known whether these results represent endothelial dysfunction as the result of a direct aldosterone effect on the vasculature or a secondary effect attributable to more substantial hypertension.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• aldosteronism with hyperaldosterone

• older than 18 year of age

• completed the informed consent

Exclusion Criteria:

• pregnancy

• bed-ridden

• could not do MRI

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aldosteronism
• Hyperaldosteronism

Intervention

Other:
• with the clinical treatment ( ex adrenalectomy or spironolactone
with the clinical observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (3)

Chang HW, Chu TS, Huang HY, Chueh SC, Wu VC, Chen YM, Hsieh BS, Wu KD. Down-regulation of D2 dopamine receptor and increased protein kinase Cmu phosphorylation in aldosterone-producing adenoma play roles in aldosterone overproduction. J Clin Endocrinol Metab. 2007 May;92(5):1863-70. Epub 2007 Feb 13. — View Citation

Chang HW, Wu VC, Huang CY, Huang HY, Chen YM, Chu TS, Wu KD, Hsieh BS. D4 dopamine receptor enhances angiotensin II-stimulated aldosterone secretion through PKC-epsilon and calcium signaling. Am J Physiol Endocrinol Metab. 2008 Mar;294(3):E622-9. doi: 10.1152/ajpendo.00657.2007. Epub 2008 Jan 2. — View Citation

Wu VC, Chueh SC, Chang HW, Lin WC, Liu KL, Li HY, Lin YH, Wu KD, Hsieh BS. Bilateral aldosterone-producing adenomas: differentiation from bilateral adrenal hyperplasia. QJM. 2008 Jan;101(1):13-22. doi: 10.1093/qjmed/hcm101. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of fibrosis and endothelium parameter		post operation or taking spirolactone 4m, 12m	Yes
Secondary	Cardiovascular events		post operation or taking spirolactone for 5 years	Yes