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Postoperative Cardiovascular Index Change of Primary Aldosteronism (TAIPAI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00746070
First received: September 1, 2008
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postoperative Cardiovascular Index Change of Primary Aldosteronism

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Change of fibrosis and endothelium parameter [ Time Frame: post operation or taking spirolactone 4m, 12m ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiovascular events [ Time Frame: post operation or taking spirolactone for 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • bed-ridden
  • could not do MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746070

Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Yen-Hun Lin, MD NTUH
  More Information

Publications:
Responsible Party: VinCent Wu, Nation Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00746070     History of Changes
Other Study ID Numbers: 200611031R
Study First Received: September 1, 2008
Last Updated: May 3, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cardiovascular disease, endothelium function, aldosterone

Additional relevant MeSH terms:
Hyperaldosteronism
Adrenal Gland Diseases
Adrenocortical Hyperfunction
Endocrine System Diseases
Spironolactone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014