HyperaldosteronismNCT00407784
Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
An observational study of Hyperaldosteronism and Hypertension, run by Erasmus Medical Center at 13 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperaldosteronism, Hypertension
- What is being tested?
- eplerenone
- How many people
- 500 participants
- Where
- 13 sitesNetherlands
- Study dates
- Jan 2007to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- blood pressure above 140 mmHg systolic and above 90 mmHg diastolic
- use of at least 2 antihypertensive drugs
Who cannot join
- 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
Show all 10Show fewer
- angina pectoris
- pregnancy
- neoplastic disease, within 5 years before inclusion
- alcohol abuse
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites, 13 recruiting
- Not yet recruiting
Academical Medical Center
Amsterdam
- Not yet recruiting
VU medical Center
Amsterdam
- Not yet recruiting
IJsselland Hospital
Capelle aan den IJssel
- Not yet recruiting
Beatrix Hospital
Gorinchem
- Not yet recruiting
University Medical Center St. Radboud
Nijmegen
- Recruiting
Erasmus Medical Center
Rotterdam
- Recruiting
Ikazia Hospital
Rotterdam
- Not yet recruiting
MCRZ, lokation Zuider/Clara
Rotterdam
- Not yet recruiting
Oogziekenhuis
Rotterdam
- Not yet recruiting
Sint Franciscus Gasthuis
Rotterdam
- Not yet recruiting
Vlietland Hospital
Schiedam
- Not yet recruiting
Ruwaard van Putten Hospital
Spijkenisse
- Not yet recruiting
Twee Steden Ziekenhuis
Waalwijk
About this study
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.
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.
Read the 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.
- Conditions
- Hyperaldosteronism, Hypertension
- Being tested
- eplerenone
- Keywords
- primary aldosteronism, hypertension, aldosteron-renin ratio, eplerenone, aldosteron-receptor antagonist, screening
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eplerenoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startJan 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, Pfizer
- Investigators
- A.H. van den Meiracker, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407784
- Sponsor's protocol ID
- MEC-2006-103
- Other IDs
- C05.2151, EudraCT nr: 2006-006618-13
- Status last verified
- Mar 2007
- First submitted
- 4 Dec 2006
- Last updated
- 7 Mar 2007
- Results posted
- No
Publications
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.
PubMed 7030245Gordon 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.
PubMed 8158400Strauch 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.
PubMed 12756408Stowasser 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.
PubMed 14597859Schwartz 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.
PubMed 15681560Giacchetti 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.
PubMed 16531803Kaplan NM. The current epidemic of primary aldosteronism: causes and consequences. J Hypertens. 2004 May;22(5):863-9. doi: 10.1097/00004872-200405000-00001.
PubMed 15097219
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00407784
- Acronym / sponsor ID
- MEC-2006-103
- Conditions
- Hyperaldosteronism, Hypertension
- Keywords
- primary aldosteronism, hypertension, aldosteron-renin ratio, eplerenone, aldosteron-receptor antagonist, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, Pfizer
- Study start
- Jan 2007
- Study completion
- Nov 2009
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65 years
- blood pressure above 140 mmHg systolic and above 90 mmHg diastolic
- use of at least 2 antihypertensive drugs
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eplerenone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2007.
- Background: PubMed 7030245Hiramatsu 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.
- Background: PubMed 8158400Gordon 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.
- Background: PubMed 12756408Strauch 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.
- Background: PubMed 14597859Stowasser 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.
- Background: PubMed 15681560Schwartz 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.
- Background: PubMed 16531803Giacchetti 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.
- Background: PubMed 15097219Kaplan NM. The current epidemic of primary aldosteronism: causes and consequences. J Hypertens. 2004 May;22(5):863-9. doi: 10.1097/00004872-200405000-00001.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.H. van den Meiracker, MD, PhD principal investigator
Erasmus Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperaldosteronism and Hypertension, run by Erasmus Medical Center at 13 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter Jansen, MD (+31(0)-4632196, p.jansen.1@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407784, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2007.