Postoperative Cardiovascular Index Change of Primary Aldosteronism

NCT ID: NCT00746070

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Aldosteronism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A, primary aldosteronism

patients approved to be aldosteronism

with the clinical treatment ( ex adrenalectomy or spironolactone

Intervention Type: OTHER

with the clinical observational study

B, essential hypertension

patients approved to be essential hypertension

No interventions assigned to this group

Interventions

with the clinical treatment ( ex adrenalectomy or spironolactone

with the clinical observational study

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nation Taiwan University Hospital

Principal Investigators

Yen-Hun Lin, MD

Role: STUDY_CHAIR

NTUH

References

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.

Reference Type: BACKGROUND

PMID: 18203722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18171914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17299068 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26477337 (View on PubMed)

Other Identifiers

200611031R

Identifier Type: -

Identifier Source: org_study_id