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Sponsors and Collaborators: |
Erasmus Medical Center Nierstichting Nederland (Dutch Kidney Foundation) Pfizer |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00407784 |
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.
Condition | Intervention |
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Hyperaldosteronism Hypertension |
Drug: eplerenone |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
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. |
Estimated Enrollment: | 500 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | November 2009 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pieter Jansen, MD | +31(0)-4632196 | p.jansen.1@erasmusmc.nl |
Contact: A.H. van den Meiracker, MD, PhD | +31(0)-4634220 | a.vandenmeiracker@erasmusmc.nl |
Netherlands | |
Erasmus Medical Center | Recruiting |
Rotterdam, Netherlands | |
MCRZ, lokation Zuider/Clara | Not yet recruiting |
Rotterdam, Netherlands | |
Beatrix Hospital | Not yet recruiting |
Gorinchem, Netherlands | |
Sint Franciscus Gasthuis | Not yet recruiting |
Rotterdam, Netherlands | |
Ikazia Hospital | Recruiting |
Rotterdam, Netherlands | |
University Medical Center St. Radboud | Not yet recruiting |
Nijmegen, Netherlands | |
Oogziekenhuis | Not yet recruiting |
Rotterdam, Netherlands | |
Ruwaard van Putten Hospital | Not yet recruiting |
Spijkenisse, Netherlands | |
Vlietland Hospital | Not yet recruiting |
Schiedam, Netherlands | |
Academical Medical Center | Not yet recruiting |
Amsterdam, Netherlands | |
VU medical Center | Not yet recruiting |
Amsterdam, Netherlands | |
Twee Steden Ziekenhuis | Not yet recruiting |
Waalwijk, Netherlands | |
IJsselland Hospital | Not yet recruiting |
Capelle aan de IJssel, Netherlands |
Principal Investigator: | A.H. van den Meiracker, MD, PhD | Erasmus Medical Center |
Study ID Numbers: | MEC-2006-103, C05.2151, EudraCT nr: 2006-006618-13 |
Study First Received: | December 4, 2006 |
Last Updated: | March 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00407784 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
primary aldosteronism hypertension aldosteron-renin ratio |
eplerenone aldosteron-receptor antagonist screening |
Eplerenone Vascular Diseases Endocrine System Diseases Adrenal Gland Diseases Endocrinopathy |
Conn's syndrome Adrenocortical Hyperfunction Hyperaldosteronism Primary aldosteronism Hypertension |
Aldosterone Antagonists Hormone Antagonists Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Pharmacologic Actions |