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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2007 by Erasmus Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407784
First Posted: December 5, 2006
Last Update Posted: March 7, 2007
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.
Collaborators:
Dutch Kidney Foundation
Pfizer
Information provided by:
Erasmus Medical Center
  Purpose
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
Hyperaldosteronism Hypertension Drug: eplerenone

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Estimated Enrollment: 500
Study Start Date: January 2007
Estimated Study Completion Date: November 2009
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

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00407784


Contacts
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

Locations
Netherlands
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
Pfizer
Investigators
Principal Investigator: A.H. van den Meiracker, MD, PhD Erasmus Medical Center
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00407784     History of Changes
Other Study ID Numbers: MEC-2006-103
C05.2151
EudraCT nr: 2006-006618-13
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: March 7, 2007
Last Verified: March 2007

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

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