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

Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperaldosteronism; Hypertension

Intervention: eplerenone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
A.H. van den Meiracker, MD, PhD, Principal Investigator, Affiliation: Erasmus Medical Center

Overall contact:
Pieter Jansen, MD, Phone: +31(0)-4632196, Email: p.jansen.1@erasmusmc.nl

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.

Clinical Details

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.

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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Pieter Jansen, MD, Phone: +31(0)-4632196, Email: p.jansen.1@erasmusmc.nl

Academical Medical Center, Amsterdam, Netherlands; Not yet recruiting

VU medical Center, Amsterdam, Netherlands; Not yet recruiting

IJsselland Hospital, Capelle aan de IJssel, Netherlands; Not yet recruiting

Beatrix Hospital, Gorinchem, Netherlands; Not yet recruiting

University Medical Center St. Radboud, Nijmegen, Netherlands; Not yet recruiting

Erasmus Medical Center, Rotterdam, Netherlands; Recruiting

Ikazia Hospital, Rotterdam, Netherlands; Recruiting

MCRZ, lokation Zuider/Clara, Rotterdam, Netherlands; Not yet recruiting

Oogziekenhuis, Rotterdam, Netherlands; Not yet recruiting

Sint Franciscus Gasthuis, Rotterdam, Netherlands; Not yet recruiting

Vlietland Hospital, Schiedam, Netherlands; Not yet recruiting

Ruwaard van Putten Hospital, Spijkenisse, Netherlands; Not yet recruiting

Twee Steden Ziekenhuis, Waalwijk, Netherlands; Not yet recruiting

Additional Information

Related publications:

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.

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.

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.

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.

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.

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.

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

Starting date: January 2007
Last updated: March 6, 2007

Page last updated: August 23, 2015

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