NCT04115280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

April 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3.3 years

First QC Date

October 2, 2019

Last Update Submit

August 21, 2023

Conditions

Primary AldosteronismAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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)

Interventions

Primary Hyperaldosteronism diagnosticDIAGNOSTIC_TEST

blood sample to obtain the aldosterone to renin ratio

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertensive patients aged of 18 to 65 years with atrial arrhythmia.

You may not qualify if:

  • BMI above 30
  • Any situation where the discontinuation of treatments (including betablockers and diuretics) presents a risk according to the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Bordeaux

Bordeaux, France

Location

CH de Pau

Pau, France

Location

MeSH Terms

Conditions

HyperaldosteronismAtrial Fibrillation

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 4, 2019

Study Start

April 16, 2020

Primary Completion

July 26, 2023

Study Completion

July 26, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)