Primary AldosteronismHAPAANCT04115280
Prevalence of Primary Aldosteronism Among Hypertensive Patients With Atrial Arythmia
A study testing Primary Hyperaldosteronism diagnostic in people with Primary Aldosteronism and Atrial Fibrillation, run by Centre Hospitalier de PAU at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Aldosteronism, Atrial Fibrillation
- What is being tested?
- Primary Hyperaldosteronism diagnostic
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Apr 2020to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients aged of 18 to 65 years with atrial arrhythmia.
Who cannot join
- BMI above 30
- Any situation where the discontinuation of treatments (including betablockers and diuretics) presents a risk according to the investigator
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Aldosteronism, Atrial Fibrillation
- Being tested
- Primary Hyperaldosteronism diagnostic
- Medical subject headings
- Hyperaldosteronism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Hyperaldosteronism diagnosticDiagnostic test
blood sample to obtain the aldosterone to renin ratio
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the prevalence of primary hyperaldosteronism
Prevalence of primary hyperaldosteronism among the enrolled population.
Measured: Data collected after the saline infusion test (6-month visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start16 Apr 2020
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de PAU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115280
- Sponsor's protocol ID
- CHPAU2019/01
- Acronym
- HAPAA
- Status last verified
- Aug 2023
- First submitted
- 2 Oct 2019
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia
- ClinicalTrials.gov ID
- NCT04115280
- Acronym / sponsor ID
- HAPAA / CHPAU2019/01
- Conditions
- Primary Aldosteronism, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier de PAUUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertensive patients aged of 18 to 65 years with atrial arrhythmia.
Key exclusion criteria (2 listed)
- BMI above 30
- Any situation where the discontinuation of treatments (including betablockers and diuretics) presents a risk according to the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Hyperaldosteronism diagnosticblood sample to obtain the aldosterone to renin ratio | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Hyperaldosteronism diagnostic in people with Primary Aldosteronism and Atrial Fibrillation, run by Centre Hospitalier de PAU at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the prevalence of primary hyperaldosteronism (time frame: Data collected after the saline infusion test (6-month visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.