Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia

Atrial Fibrillation Clinical Trial

— HAPAA  

Official title:

Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115280
• Other study ID #: CHPAU2019/01
• Status: Completed
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: July 26, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier de PAU
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hyperaldosteronism
• Primary Aldosteronism

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CH de Pau	PAU

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de PAU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the prevalence of primary hyperaldosteronism	Prevalence of primary hyperaldosteronism among the enrolled population.	Data collected after the saline infusion test (6-month visit)