|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00407784 |
|
Date of registration:
|
04/12/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Diagnostic Properties of Aldosterone-Renin Ratio in Primary Aldosteronism Among Hypertensives.
|
|
Scientific 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. |
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
500 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00407784 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Pieter Jansen, MD |
|
Address:
|
|
|
Telephone:
|
+31(0)-4632196 |
|
Email:
|
p.jansen.1@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
A.H. van den Meiracker, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Erasmus Medical Center |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypertension
|
|
Hyperaldosteronism
|
|
Intervention(s)
|
|
Drug: eplerenone
|
|
Secondary ID(s)
|
|
C05.2151
|
|
MEC-2006-103
|
|
EudraCT nr: 2006-006618-13
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|