Primary AldosteronismNCT03789357
Prevalence of Primary Aldosteronism in Patients With Stroke
An observational study of Primary Aldosteronism and Stroke, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Strokes leads to significant morbidity and mortality, and hypertension is the most important risk factor for strokes. It is estimated that up to 10% of patients with hypertension have the underlying, treatable condition of primary aldosteronism. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Primary Aldosteronism, Stroke
- What is being tested?
- Aldosterone renin ratio
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2018to 30 Sep 2021
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Adult, Older adult
Study population: Prospective study to evaluate the prevalence of primary aldosteronism in patients with an acute stroke. 300 patients admitted with CVA/TIA will be enrolled into the study.
Who may be able to join
- Age 21-80 years
- Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH
- Patients with both ischemic and hemorrhagic strokes
Who cannot join
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Strokes leads to significant morbidity and mortality, and hypertension is the most important risk factor for strokes. It is estimated that up to 10% of patients with hypertension have the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the prevalence of primary aldosteronism is high in patients with strokes, a complication of long-standing hypertension.
Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital, will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests will be done with saline-infusion test.
- Conditions
- Primary Aldosteronism, Stroke
- Being tested
- Aldosterone renin ratio
- Keywords
- Hypertension, Arrhythmia, Adrenal vein sampling, Mineralocorticoid-receptor Antagonists
- Medical subject headings
- Hyperaldosteronism, Stroke, Hypertension, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldosterone renin ratioDiagnostic test
Aldosterone Renin Ratio to screen for Primary Aldosteronism
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | All patients admitted to the Acute Stroke Unit Receives: Diagnostic Test: Aldosterone renin ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke
Percentage of patients with confirmed Primary Aldosteronism using confirmatory test
Measured: 6 months
Secondary outcomes (5)
Accuracy of Screening test in early period post-stroke
To determine if the screening blood test for primary aldosteronism performed within 1 week post-stroke is equally accurate compared to being performed 2-4 months post-stroke.
Measured: 3 months
Percentage of unilateral primary aldosteronism in patients admitted with acute stroke
Percentage of unilateral PA amongst patients with stroke
Measured: 6 months
Percentage of patients with positive screening test in patients admitted with acute stroke
Measured: 3 months
Blood pressure change after treatment for primary aldosteronism
Measured: 12 months
Cardiac Complications
Cardiac complications in patients with primary aldosteronism, compared to those without primary aldosteronism, as assessed by transthoracic echocardiography features of left ventricular hypertrophy / mass, and diastolic dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 May 2018
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy Puar, MRCP UK, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789357
- Sponsor's protocol ID
- PA_CVA
- Status last verified
- May 2022
- First submitted
- 19 Dec 2018
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen V, Tu TM, Mamauag MJB, Lai J, Saffari SE, Aw TC, Ong L, Foo RSY, Chai SC, Fones S, Zhang M, Puar TH. Primary Aldosteronism More Prevalent in Patients With Cardioembolic Stroke and Atrial Fibrillation. Front Endocrinol (Lausanne). 2022 Apr 19;13:869980. doi: 10.3389/fendo.2022.869980. eCollection 2022.
PubMed 35518929
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Primary Aldosteronism in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03789357
- Acronym / sponsor ID
- PA_CVA
- Conditions
- Primary Aldosteronism, Stroke
- Keywords
- Hypertension, Arrhythmia, Adrenal vein sampling, Mineralocorticoid-receptor Antagonists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Dec 2018 (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.
Strokes leads to significant morbidity and mortality, and hypertension is the most important risk factor for strokes. It is estimated that up to 10% of patients with hypertension have the underlying, treatable condition of primary aldosteronism. Hence, we hypothesize that the prevalence of primary aldosteronism is high in patients with strokes, a complication of long-standing hypertension.
Patients admitted with an acute stroke to the Acute Stroke Unit, Changi General Hospital, will be screened for Primary Aldosteronism three months post-stroke, and confirmatory tests will be done with saline-infusion test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Diagnostic Test: Aldosterone renin ratioAll patients admitted to the Acute Stroke Unit |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prospective study to evaluate the prevalence of primary aldosteronism in patients with an acute stroke. 300 patients admitted with CVA/TIA will be enrolled into the study.
Key inclusion criteria (3 listed)
- Age 21-80 years
- Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH
- Patients with both ischemic and hemorrhagic strokes
Key exclusion criteria (1 listed)
- Pregnant patients
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 |
|---|---|---|
| Aldosterone renin ratioAldosterone Renin Ratio to screen for Primary Aldosteronism | Diagnostic test | Single Arm |
Primary outcome
Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke
Time frame: 6 months
Percentage of patients with confirmed Primary Aldosteronism using confirmatory test
5 secondary outcomes
Accuracy of Screening test in early period post-stroke
Time frame: 3 months
Percentage of unilateral primary aldosteronism in patients admitted with acute stroke
Time frame: 6 months
Percentage of patients with positive screening test in patients admitted with acute stroke
Time frame: 3 months
Blood pressure change after treatment for primary aldosteronism
Time frame: 12 months
Cardiac Complications
Time frame: 6 months
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 20 May 2022.
- Derived from this study: PubMed 35518929Nguyen V, Tu TM, Mamauag MJB, Lai J, Saffari SE, Aw TC, Ong L, Foo RSY, Chai SC, Fones S, Zhang M, Puar TH. Primary Aldosteronism More Prevalent in Patients With Cardioembolic Stroke and Atrial Fibrillation. Front Endocrinol (Lausanne). 2022 Apr 19;13:869980. doi: 10.3389/fendo.2022.869980. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Primary Aldosteronism
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Primary Aldosteronism
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.
Troy Puar, MRCP UK principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Stroke, run by Changi General Hospital at 1 site in Singapore.
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 3 inclusion and 1 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 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03789357, which also lists 1 linked publication.
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 20 May 2022.