Clinical trial NCT00407784: Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperaldosteronism
Hypertension
Keywords: primary aldosteronism
hypertension
aldosteron-renin ratio
eplerenone
aldosteron-receptor antagonist
screening
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
name: Pfizer
First posted: 2006-12-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academical Medical Center
city: Amsterdam
country: Netherlands
facility: VU medical Center
city: Capelle aan de IJssel
country: Netherlands
facility: IJsselland Hospital
city: Gorinchem
country: Netherlands
facility: Beatrix Hospital
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Rotterdam
country: Netherlands
facility: MCRZ, lokation Zuider/Clara
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Schiedam
country: Netherlands
facility: Vlietland Hospital
city: Spijkenisse
country: Netherlands
facility: Ruwaard van Putten Hospital
city: Waalwijk
country: Netherlands
facility: Twee Steden Ziekenhuis
Study officials:
affiliation: Erasmus Medical Center
name: A.H. van den Meiracker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
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. doi: 10.1038/sj.jhh.1001554.
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. doi: 10.1097/00004872-200311000-00025.
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. doi: 10.1373/clinchem.2004.041780.
citation: 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. doi: 10.1097/01.hjh.0000217857.20241.0f.
citation: Kaplan NM. The current epidemic of primary aldosteronism: causes and consequences. J Hypertens. 2004 May;22(5):863-9. doi: 10.1097/00004872-200405000-00001.