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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407784
Recruitment Status : Unknown
Verified March 2007 by Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : December 5, 2006
Last Update Posted : March 7, 2007
Dutch Kidney Foundation
Information provided by:
Erasmus Medical Center

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.

Condition or disease Intervention/treatment
Hyperaldosteronism Hypertension Drug: eplerenone

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.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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 Start Date : January 2007
Estimated Study Completion Date : November 2009

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407784

Contact: Pieter Jansen, MD +31(0)-4632196
Contact: A.H. van den Meiracker, MD, PhD +31(0)-4634220

Academical Medical Center Not yet recruiting
Amsterdam, Netherlands
VU medical Center Not yet recruiting
Amsterdam, Netherlands
IJsselland Hospital Not yet recruiting
Capelle aan de IJssel, Netherlands
Beatrix Hospital Not yet recruiting
Gorinchem, Netherlands
University Medical Center St. Radboud Not yet recruiting
Nijmegen, Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Ikazia Hospital Recruiting
Rotterdam, Netherlands
MCRZ, lokation Zuider/Clara Not yet recruiting
Rotterdam, Netherlands
Oogziekenhuis Not yet recruiting
Rotterdam, Netherlands
Sint Franciscus Gasthuis Not yet recruiting
Rotterdam, Netherlands
Vlietland Hospital Not yet recruiting
Schiedam, Netherlands
Ruwaard van Putten Hospital Not yet recruiting
Spijkenisse, Netherlands
Twee Steden Ziekenhuis Not yet recruiting
Waalwijk, Netherlands
Sponsors and Collaborators
Erasmus Medical Center
Dutch Kidney Foundation
Principal Investigator: A.H. van den Meiracker, MD, PhD Erasmus Medical Center

Publications: Identifier: NCT00407784     History of Changes
Other Study ID Numbers: MEC-2006-103
EudraCT nr: 2006-006618-13
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: March 7, 2007
Last Verified: March 2007

Keywords provided by Erasmus Medical Center:
primary aldosteronism
aldosteron-renin ratio
aldosteron-receptor antagonist

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents