NCT00407784

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 7, 2007

Status Verified

March 1, 2007

First QC Date

December 4, 2006

Last Update Submit

March 6, 2007

Conditions

HyperaldosteronismHypertension

Keywords

primary aldosteronismhypertensionaldosteron-renin ratioeplerenonealdosteron-receptor antagonistscreening

Interventions

eplerenoneDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-65 years
  • blood pressure above 140 mmHg systolic and above 90 mmHg diastolic
  • use of at least 2 antihypertensive drugs

You may not qualify if:

  • 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
  • angina pectoris
  • pregnancy
  • alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Academical Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

VU medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

IJsselland Hospital

Capelle aan den IJssel, Netherlands

NOT YET RECRUITING

Beatrix Hospital

Gorinchem, Netherlands

NOT YET RECRUITING

University Medical Center St. Radboud

Nijmegen, Netherlands

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Ikazia Hospital

Rotterdam, Netherlands

RECRUITING

MCRZ, lokation Zuider/Clara

Rotterdam, Netherlands

NOT YET RECRUITING

Oogziekenhuis

Rotterdam, Netherlands

NOT YET RECRUITING

Sint Franciscus Gasthuis

Rotterdam, Netherlands

NOT YET RECRUITING

Vlietland Hospital

Schiedam, Netherlands

NOT YET RECRUITING

Ruwaard van Putten Hospital

Spijkenisse, Netherlands

NOT YET RECRUITING

Twee Steden Ziekenhuis

Waalwijk, Netherlands

NOT YET RECRUITING

Related Publications (7)

  • 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.

    PMID: 7030245BACKGROUND

  • 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.

    PMID: 8158400BACKGROUND

  • 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.

    PMID: 12756408BACKGROUND

  • 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.

    PMID: 14597859BACKGROUND

  • 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.

    PMID: 15681560BACKGROUND

  • 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.

    PMID: 16531803BACKGROUND

  • 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.

    PMID: 15097219BACKGROUND

MeSH Terms

Conditions

HyperaldosteronismHypertension

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • A.H. van den Meiracker, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Jansen, MD

CONTACT

+31(0)-4632196p.jansen.1@erasmusmc.nl

A.H. van den Meiracker, MD, PhD

CONTACT

+31(0)-4634220a.vandenmeiracker@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

January 1, 2007

Study Completion

November 1, 2009

Last Updated

March 7, 2007

Record last verified: 2007-03

Locations

NL(13)