Prevalence of Primary Aldosteronism in Patients With Stroke

Completed

• Conditions: Stroke; Primary Aldosteronism
• Interventions: Diagnostic Test: Aldosterone renin ratio

• Registration Number: NCT03789357
• Lead Sponsor: Changi General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

a. Pregnant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Aldosterone renin ratio	All patients admitted to the Acute Stroke Unit

Primary Outcome Measures

Name	Time	Method
Percentage of patients with stroke with confirmed primary aldosteronism in patients admitted to the acute stroke unit for stroke	6 months	Percentage of patients with confirmed Primary Aldosteronism using confirmatory test

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with positive screening test in patients admitted with acute stroke	3 months
Percentage of unilateral primary aldosteronism in patients admitted with acute stroke	6 months	Percentage of unilateral PA amongst patients with stroke
Blood pressure change after treatment for primary aldosteronism	12 months
Accuracy of Screening test in early period post-stroke	3 months	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.
Cardiac Complications	6 months	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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore