Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
Recruitment status was Recruiting
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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. |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 | |
| VU medical Center | Not yet recruiting |
| Amsterdam, Netherlands | |
| Academical 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 | |
| Sint Franciscus Gasthuis | Not yet recruiting |
| Rotterdam, Netherlands | |
| MCRZ, lokation Zuider/Clara | Not yet recruiting |
| Rotterdam, Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands | |
| Ikazia Hospital | Recruiting |
| Rotterdam, Netherlands | |
| Oogziekenhuis | 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 | |
| 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 |
| Study First Received: | December 4, 2006 |
| Last Updated: | March 6, 2007 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Erasmus Medical Center:
|
primary aldosteronism hypertension aldosteron-renin ratio |
eplerenone aldosteron-receptor antagonist screening |
Additional relevant MeSH terms:
|
Hyperaldosteronism Hypertension Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Antihypertensive Agents |
Eplerenone Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013