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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Dutch Kidney Foundation
Pfizer
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00407784
First received: December 4, 2006
Last updated: March 6, 2007
Last verified: March 2007

December 4, 2006
March 6, 2007
January 2007
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Complete list of historical versions of study NCT00407784 on ClinicalTrials.gov Archive Site
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Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
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.

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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  • Hyperaldosteronism
  • Hypertension
Drug: eplerenone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
November 2009
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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
Both
18 Years to 65 Years
No
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
 
NCT00407784
MEC-2006-103, C05.2151, EudraCT nr: 2006-006618-13
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Erasmus Medical Center
  • Dutch Kidney Foundation
  • Pfizer
Principal Investigator: A.H. van den Meiracker, MD, PhD Erasmus Medical Center
Erasmus Medical Center
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP