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

NCT00407784

Last updated date
Study Location
Oogziekenhuis
Rotterdam, , , Netherlands
Contact
+31(0)-4632196

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperaldosteronism, Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- age 18-65 years

- blood pressure above 140 mmHg systolic and above 90 mmHg diastolic

- use of at least 2 antihypertensive drugs

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Hyperaldosteronism, HypertensionDiagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
NCT00407784
  1. Rotterdam,
  2. Gorinchem,
  3. Amsterdam,
  4. Capelle aan de IJssel,
  5. Waalwijk,
  6. Rotterdam,
  7. Rotterdam,
  8. Spijkenisse,
  9. Nijmegen,
  10. Amsterdam,
  11. Rotterdam,
  12. Schiedam,
  13. Rotterdam,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
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.
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.
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 Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Hyperaldosteronism
  • Hypertension
Intervention Drug: eplerenone
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: December 4, 2006)
500
Original Enrollment Same as current
Study Completion Date November 2009
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00407784
Other Study ID Numbers MEC-2006-103
C05.2151
EudraCT nr: 2006-006618-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Erasmus Medical Center
Collaborators
  • Dutch Kidney Foundation
  • Pfizer
Investigators
Principal Investigator:A.H. van den Meiracker, MD, PhDErasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date March 2007