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

Primary Purpose

Primary Aldosteronism, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Primary Hyperaldosteronism diagnostic
Sponsored by
Centre Hospitalier de PAU
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Aldosteronism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux
  • CH de Pau

Outcomes

Primary Outcome Measures

Evaluation of the prevalence of primary hyperaldosteronism
Prevalence of primary hyperaldosteronism among the enrolled population.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2019
Last Updated
August 21, 2023
Sponsor
Centre Hospitalier de PAU
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1. Study Identification

Unique Protocol Identification Number
NCT04115280
Brief Title
Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia
Acronym
HAPAA
Official Title
Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
July 26, 2023 (Actual)
Study Completion Date
July 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de PAU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism, Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Primary Hyperaldosteronism diagnostic
Intervention Description
blood sample to obtain the aldosterone to renin ratio
Primary Outcome Measure Information:
Title
Evaluation of the prevalence of primary hyperaldosteronism
Description
Prevalence of primary hyperaldosteronism among the enrolled population.
Time Frame
Data collected after the saline infusion test (6-month visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
CH de Pau
City
PAU
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia

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