Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.

Hypertension Clinical Trial

Official title:

Aldosterone-Renin Ratio to Diagnose Primary Aldosteronism in a Population of Patients With Therapy-Resistant Hypertension: Test Characteristics, Diagnostic Value and Predictive Value for Antihypertensive Treatment. The Dutch ARRAT Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00407784
• Other study ID #: MEC-2006-103
• Secondary ID: C05.2151EudraCT
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2006
• Last updated: March 6, 2007
• Start date: January 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2007
• Source: Erasmus Medical Center
• Contact: Pieter Jansen, MD
• Phone: +31(0)-4632196
• Email: p.jansen.1[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the diagnostic value of the Aldosterone-Renin Ratio (ARR)as a screening test for primary aldosteronism among hypertensives. The test characteristics will be studied. Furthermore, the effect of eplerenone, a selective aldosterone-receptor antagonist will be studied.

Description:

Although primary aldosteronism (PA) was formerly seen as a rare cause of hypertension, this condition is now thought to be the commonest cause of secondary hypertension, with the prevalence ranging up to 10-15 % of all hypertensives. Identification of patients with PA allows for specific treatment, for instance unilateral adrenalectomy in case of an aldosterone-producing adenoma or the administration of an aldosterone-receptor antagonist in case of bilateral adrenal hyperplasia.

Since the introduction of the aldosterone-renin ratio (ARR) as a screening tool for PA in 1981, there has been considerable debate about the diagnostic value. The values for aldosterone and renin are highly dependent on many factors, including posture, time of day and medication. Also, the cut-off values for the identification of PA remain controversial.

This study aims to evaluate the test characteristics of the ARR in a population of patients with therapy-resistant hypertension, the dependence of the ARR on medication type and the predictive value on the response on eplerenone, a selective aldosterone-receptor antagonist.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years

• blood pressure above 140 mmHg systolic and above 90 mmHg diastolic

• use of at least 2 antihypertensive drugs

Exclusion Criteria:

• known cause of hypertension, including white-coat hypertension

• severe renal failure (kreat > 200 umol/l)

• BMI above 32 kg/m2

• poorly regulated diabetes mellitus (HbA1C > 8.0 %)

• heart failure

• stroke or myocardial infarction within 6 months before inclusion

• angina pectoris

• pregnancy

• neoplastic disease, within 5 years before inclusion

• alcohol abuse

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension

Intervention

Drug:
• eplerenone

Locations

Country	Name	City	State
Netherlands	Academical Medical Center	Amsterdam
Netherlands	VU medical Center	Amsterdam
Netherlands	IJsselland Hospital	Capelle aan de IJssel
Netherlands	Beatrix Hospital	Gorinchem
Netherlands	University Medical Center St. Radboud	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Ikazia Hospital	Rotterdam
Netherlands	MCRZ, lokation Zuider/Clara	Rotterdam
Netherlands	Oogziekenhuis	Rotterdam
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Netherlands	Vlietland Hospital	Schiedam
Netherlands	Ruwaard van Putten Hospital	Spijkenisse
Netherlands	Twee Steden Ziekenhuis	Waalwijk

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Dutch Kidney Foundation, Pfizer

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Giacchetti G, Ronconi V, Lucarelli G, Boscaro M, Mantero F. Analysis of screening and confirmatory tests in the diagnosis of primary aldosteronism: need for a standardized protocol. J Hypertens. 2006 Apr;24(4):737-45. — View Citation

Gordon RD, Klemm SA, Stowasser M, Tunny TJ, Storie WJ, Rutherford JC. How common is primary aldosteronism? Is it the most frequent cause of curable hypertension? J Hypertens Suppl. 1993 Dec;11(5):S310-1. — View Citation

Hiramatsu K, Yamada T, Yukimura Y, Komiya I, Ichikawa K, Ishihara M, Nagata H, Izumiyama T. A screening test to identify aldosterone-producing adenoma by measuring plasma renin activity. Results in hypertensive patients. Arch Intern Med. 1981 Nov;141(12):1589-93. — View Citation

Kaplan NM. The current epidemic of primary aldosteronism: causes and consequences. J Hypertens. 2004 May;22(5):863-9. Review. — View Citation

Schwartz GL, Turner ST. Screening for primary aldosteronism in essential hypertension: diagnostic accuracy of the ratio of plasma aldosterone concentration to plasma renin activity. Clin Chem. 2005 Feb;51(2):386-94. — View Citation

Stowasser M, Gordon RD, Gunasekera TG, Cowley DC, Ward G, Archibald C, Smithers BM. High rate of detection of primary aldosteronism, including surgically treatable forms, after 'non-selective' screening of hypertensive patients. J Hypertens. 2003 Nov;21(11):2149-57. — View Citation

Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens. 2003 May;17(5):349-52. — View Citation