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

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Erasmus University

Status

Unknown

Conditions

Hypertension
Hyperaldosteronism

Treatments

Drug: eplerenone

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00407784
EudraCT nr: 2006-006618-13
C05.2151
MEC-2006-103

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

13

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Central trial contact

A.H. van den Meiracker, MD, PhD; Pieter Jansen, MD

Data sourced from clinicaltrials.gov

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