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CompletedNCT03789357Updated May 20, 2022

Prevalence of Primary Aldosteronism in Patients With Stroke

An observational study in Primary Aldosteronism and Stroke, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-20.

Sponsored by Changi General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
21 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Primary Aldosteronism
  • Stroke

Keywords

  • Hypertension
  • Arrhythmia
  • Adrenal vein sampling
  • Mineralocorticoid-receptor Antagonists
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In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 300 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Age 21-80 years
  2. Admitted with acute cerebrovascular accident (CVA) or transient ischemic attack (TIA) to the ASU, CGH
  3. Patients with both ischemic and hemorrhagic strokes

Exclusion criteria

Exclusion Criteria:

a. Pregnant patients

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • Single Arm

    All patients admitted to the Acute Stroke Unit

    Diagnostic Test: Aldosterone renin ratio

Interventions

  • Diagnostic testAldosterone renin ratio

    Aldosterone Renin Ratio to screen for Primary Aldosteronism

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. Percentage of unilateral primary aldosteronism in patients admitted with acute stroke

    Percentage of unilateral PA amongst patients with stroke

    Time frame: 6 months

  3. Percentage of patients with positive screening test in patients admitted with acute stroke

    Time frame: 3 months

  4. Blood pressure change after treatment for primary aldosteronism

    Time frame: 12 months

  5. 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

    Time frame: 6 months

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Study locations

1 site
  • Changi General Hospital
    Singapore, 529889, Singapore
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03789357
Lead sponsor
Changi General Hospital
Responsible party
Sponsor
First posted
Dec 28, 2018
Start date
May 1, 2018
Primary completion
Jul 31, 2021
Completion
Sep 30, 2021
Last update
May 20, 2022

Study contacts

Troy Puar, MRCP UK
principal investigator · Changi General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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