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Postoperative Cardiovascular Index Change of Primary Aldosteronism (TAIPAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
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.

Condition or disease Intervention/treatment
Aldosteronism Other: with the clinical treatment ( ex adrenalectomy or spironolactone

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Change of fibrosis and endothelium parameter [ Time Frame: post operation or taking spirolactone 4m, 12m ]

Secondary Outcome Measures :
  1. Cardiovascular events [ Time Frame: post operation or taking spirolactone for 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
aldosteronism Patients enrolled from initial screening test and recorded in the Taiwan Primary Aldosteornism Investigation (TAIPAI) database. The database was constructed for quality assurance since 2003 in one medical center (National Taiwan University Hospital, Taipei, Taiwan) and its three branch hospitals in different cities (National Taiwan University Hospital Yun-Lin branch, Yun-Lin, southern Taiwan; Far-Eastern Memorial Hospital, Taipei; Tao-Yuan General Hospital, Tao-Yuan, middle Taiwan). All patients with intention to confirm and requiring suppression test or adrenal venous sampling were recruited and data were prospectively collected.

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • bed-ridden
  • could not do MRI

Information from the National Library of Medicine

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 identifier (NCT number): NCT00746070

Sponsors and Collaborators
National Taiwan University Hospital
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Study Chair: Yen-Hun Lin, MD NTUH
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: VinCent Wu, Nation Taiwan University Hospital Identifier: NCT00746070    
Other Study ID Numbers: 200611031R
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: April 2010
Keywords provided by National Taiwan University Hospital:
cardiovascular disease, endothelium function, aldosterone
Additional relevant MeSH terms:
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Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents