Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C05.2151 | |||
| EudraCT nr: 2006-006618-13 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dutch Kidney Foundation | OTHER |
| Pfizer | INDUSTRY |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eplerenone | Drug |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter Jansen, MD | Contact | +31(0)-4632196 | p.jansen.1@erasmusmc.nl | |
| A.H. van den Meiracker, MD, PhD | Contact | +31(0)-4634220 | a.vandenmeiracker@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| A.H. van den Meiracker, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academical Medical Center | Not yet recruiting | Amsterdam | Netherlands | |||
| VU medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7030245 | Background | Hiramatsu K, Yamada T, Yukimura Y, Komiya I, Ichikawa K, Ishihara M, Nagata H, Izumiyama T. A screening test to identify aldosterone-producing adenoma by measuring plasma renin activity. Results in hypertensive patients. Arch Intern Med. 1981 Nov;141(12):1589-93. | |
| 8158400 | Background | Gordon RD, Klemm SA, Stowasser M, Tunny TJ, Storie WJ, Rutherford JC. How common is primary aldosteronism? Is it the most frequent cause of curable hypertension? J Hypertens Suppl. 1993 Dec;11(5):S310-1. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Not yet recruiting |
| Amsterdam |
| Netherlands |
| IJsselland Hospital | Not yet recruiting | Capelle aan den 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 |
| 12756408 | Background | Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens. 2003 May;17(5):349-52. doi: 10.1038/sj.jhh.1001554. |
| 14597859 | Background | Stowasser M, Gordon RD, Gunasekera TG, Cowley DC, Ward G, Archibald C, Smithers BM. High rate of detection of primary aldosteronism, including surgically treatable forms, after 'non-selective' screening of hypertensive patients. J Hypertens. 2003 Nov;21(11):2149-57. doi: 10.1097/00004872-200311000-00025. |
| 15681560 | Background | Schwartz GL, Turner ST. Screening for primary aldosteronism in essential hypertension: diagnostic accuracy of the ratio of plasma aldosterone concentration to plasma renin activity. Clin Chem. 2005 Feb;51(2):386-94. doi: 10.1373/clinchem.2004.041780. |
| 16531803 | Background | Giacchetti G, Ronconi V, Lucarelli G, Boscaro M, Mantero F. Analysis of screening and confirmatory tests in the diagnosis of primary aldosteronism: need for a standardized protocol. J Hypertens. 2006 Apr;24(4):737-45. doi: 10.1097/01.hjh.0000217857.20241.0f. |
| 15097219 | Background | Kaplan NM. The current epidemic of primary aldosteronism: causes and consequences. J Hypertens. 2004 May;22(5):863-9. doi: 10.1097/00004872-200405000-00001. |
| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided