Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
NCT00407784
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- age 18-65 years
- blood pressure above 140 mmHg systolic and above 90 mmHg diastolic
- use of at least 2 antihypertensive drugs
- 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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Descriptive Information | ||||
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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 |
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Intervention | Drug: eplerenone | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* 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 | 500 | |||
Original Enrollment | Same as current | |||
Study Completion Date | November 2009 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Investigators |
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PRS Account | Erasmus Medical Center | |||
Verification Date | March 2007 |