- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04115280
Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia (HAPAA)
Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia
Atrial arrhythmia is the most frequent cardiac arrhythmia. It is a source of significant morbidity.
Hypertension is a major risk factor for atrial arrhythmias. Primary hyperaldosteronism (PA) is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias with a specific, sometimes curative, treatment. The purpose of the study is to show that the prevalence of PA among hypertensive patients under 65 years old with atrial arrhythmia is high, justifying systematic screening.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Atrial arrhythmia is the most frequent cardiac arrhythmia, affecting one million patients in France. It is a source of significant morbidity, a major deterioration in the quality of life and considerable health expenditure.
Hypertension is a major and modifiable risk factor for atrial arrhythmias. Primary hyperaldosteronism is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias, but also stroke, coronary artery disease, heart and kidney failure. This form has a specific treatment, sometimes curative.
The objective of this study is to show that the prevalence of primary hyperaldosteronism among patients under 65 with atrial arrhythmias is high, justifying systematic screening in this population.
The investigators will consecutively include 65-year-old hypertensive patients hospitalized in the department with atrialarrhythmia. They will benefit from an aldosterone to renin ratio assay under standardized conditions at 3 months.
Patients whose aldosterone (pmol/l) to renin (mUI/l) ratio is greater than 64 will benefit from saline infusion test if necessary and adrenal scan. Patients with a definite diagnosis who would prefer surgical treatment will benefit from adrenal venous catheterization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bordeaux, France
- CHU de Bordeaux
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PAU, France
- CH de Pau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hypertensive patients aged of 18 to 65 years with atrial arrhythmia.
Exclusion Criteria:
- BMI above 30
- Any situation where the discontinuation of treatments (including betablockers and diuretics) presents a risk according to the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the prevalence of primary hyperaldosteronism
Time Frame: Data collected after the saline infusion test (6-month visit)
|
Prevalence of primary hyperaldosteronism among the enrolled population.
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Data collected after the saline infusion test (6-month visit)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHPAU2019/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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