NCT00746070

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

2.9 years

First QC Date

September 1, 2008

Last Update Submit

May 3, 2010

Conditions

Aldosteronism

Keywords

cardiovascular disease, endothelium function, aldosterone

Outcome Measures

Primary Outcomes (1)

  • Change of fibrosis and endothelium parameter

    post operation or taking spirolactone 4m, 12m

Secondary Outcomes (1)

  • Cardiovascular events

    post operation or taking spirolactone for 5 years

Study Arms (2)

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

with the clinical treatment ( ex adrenalectomy or spironolactoneOTHER

with the clinical observational study

A, primary aldosteronism

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • bed-ridden
  • could not do MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 18203722BACKGROUND

  • 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.

    PMID: 18171914BACKGROUND

  • 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.

    PMID: 17299068BACKGROUND

  • 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.

    PMID: 26477337DERIVED

MeSH Terms

Conditions

HyperaldosteronismCardiovascular Diseases

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yen-Hun Lin, MD

    NTUH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

January 1, 2013

Last Updated

May 4, 2010

Record last verified: 2010-04