Postoperative Cardiovascular Index Change of Primary Aldosteronism (TAIPAI)
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|ClinicalTrials.gov Identifier: NCT00746070|
Recruitment Status : Unknown
Verified April 2010 by National Taiwan University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : September 3, 2008
Last Update Posted : May 4, 2010
|Condition or disease||Intervention/treatment|
|Aldosteronism||Other: with the clinical treatment ( ex adrenalectomy or spironolactone|
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 Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Postoperative Cardiovascular Index Change of Primary Aldosteronism|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||January 2013|
A, primary aldosteronism
patients approved to be aldosteronism
Other: with the clinical treatment ( ex adrenalectomy or spironolactone
with the clinical observational study
B, essential hypertension
patients approved to be essential hypertension
- Change of fibrosis and endothelium parameter [ Time Frame: post operation or taking spirolactone 4m, 12m ]
- Cardiovascular events [ Time Frame: post operation or taking spirolactone for 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746070
|Study Chair:||Yen-Hun Lin, MD||NTUH|