CClinicalTrials.gg
Status unknownNCT00746070TAIPAIUpdated May 4, 2010

Postoperative Cardiovascular Index Change of Primary Aldosteronism

An observational study in Aldosteronism, sponsored by National Taiwan University Hospital. Status unknown. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-04.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aldosteronism

Browse trials for

Keywords

  • cardiovascular disease, endothelium function, aldosterone
03

In context

Hyperaldosteronism

193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.

This study's enrollment of 300 is above the median of 200 across 98 observational studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • pregnancy
  • bed-ridden
  • could not do MRI
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (actual)

Groups and cohorts

  • A, primary aldosteronism

    patients approved to be aldosteronism

    Other: with the clinical treatment ( ex adrenalectomy or spironolactone

  • B, essential hypertension

    patients approved to be essential hypertension

Interventions

  • Otherwith the clinical treatment ( ex adrenalectomy or spironolactone

    with the clinical observational study

06

What researchers measure

Primary outcomes

  1. Change of fibrosis and endothelium parameter

    Time frame: post operation or taking spirolactone 4m, 12m

Secondary outcomes

  1. Cardiovascular events

    Time frame: post operation or taking spirolactone for 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18203722 ↗
  • 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. PubMed 18171914 ↗
  • 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. doi: 10.1210/jc.2006-2338. Epub 2007 Feb 13. PubMed 17299068 ↗
  • Wu CH, Yang YW, Hung SC, Tsai YC, Hu YH, Lin YH, Chu TS, Wu KD, Wu VC. Effect of Treatment on Body Fluid in Patients with Unilateral Aldosterone Producing Adenoma: Adrenalectomy versus Spironolactone. Sci Rep. 2015 Oct 19;5:15297. doi: 10.1038/srep15297. PubMed 26477337 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00746070
Lead sponsor
National Taiwan University Hospital
First posted
Sep 3, 2008
Start date
Jan 2007
Primary completion
Dec 2009 (estimated)
Completion
Jan 2013 (estimated)
Last update
May 4, 2010

Study contacts

Yen-Hun Lin, MD
study chair · NTUH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion