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Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia (HAPAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115280
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de PAU

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Aldosteronism Atrial Fibrillation Diagnostic Test: Primary Hyperaldosteronism diagnostic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : October 16, 2022
Estimated Study Completion Date : October 16, 2022



Intervention Details:
  • Diagnostic Test: Primary Hyperaldosteronism diagnostic
    blood sample to obtain the aldosterone to renin ratio


Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115280


Locations
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France
CHU de Bordeaux Not yet recruiting
Bordeaux, France
Contact: Josselin DUCHATEAU    05 57 65 69 69    josselin.duchateau@gmail.com   
CH de Pau Recruiting
PAU, France
Contact: Romain BOULESTREAU    05 59 92 48 83    romain.boulestreau@ch-pau.fr   
Contact: Alice SERIS    0559726997    alice.seris@ch-pau.fr   
Sponsors and Collaborators
Centre Hospitalier de PAU
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Responsible Party: Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT04115280    
Other Study ID Numbers: CHPAU2019/01
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Hyperaldosteronism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases