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.
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | November 2009 |
Est. primary completion date | |
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 |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
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 |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Dutch Kidney Foundation, Pfizer |
Netherlands,
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
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