Postoperative Cardiovascular Index Change of Primary Aldosteronism

• Conditions: Aldosteronism
• Interventions: Other: with the clinical treatment ( ex adrenalectomy or spironolactone

• Registration Number: NCT00746070
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-01
• Study First Posted: 2008-09-03
• Primary Completion: 2009-12
• Status Verified: 2010-04
• Last Update Submitted: 2010-05-03
• Last Update Posted: 2010-05-04
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• aldosteronism with hyperaldosterone
• older than 18 year of age
• completed the informed consent

Read More

Exclusion Criteria

• pregnancy
• bed-ridden
• could not do MRI

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A, primary aldosteronism	with the clinical treatment ( ex adrenalectomy or spironolactone	patients approved to be aldosteronism

Primary Outcome Measures

Name	Time	Method
Change of fibrosis and endothelium parameter	post operation or taking spirolactone 4m, 12m

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events	post operation or taking spirolactone for 5 years