Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Phase 1

• Conditions: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
• Interventions: Diagnostic Test: Brain MRI

• Registration Number: NCT03821571
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Hypertension is known to be the major risk factor for stroke. The most common cause of secondary hypertension, primary aldosteronism (PA), is characterized by the excessive secretion of aldosterone and is related to hypertension and hypokalemia. PA accounts for 3-10 % of hypertensive patients, and a higher incidence of vascular complications compared to patients with essential hypertension was observed in several studies. The vascular injury from excessive aldosterone can occur via oxidative stress and collagen remodeling, causing endothelial dysfunction and fibrosis in the vasculature.

The association between cerebral small vessel disease (cSVD) and hypertension has been well studies in the past decades. However, not much study has focused on the cSVD burden in patient with PA. The goal of this study is to understand the features of cSVD in patients with PA and for the purpose of understanding the underlying pathophysiology of cerebrovascular injury in this particular patient group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-24
• Study Start: 2019-01-25
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age between 20-90 years-old
• patient with primary aldosteronism or healthy control
• consciousness clear
• willing to receive brain MRI

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Exclusion Criteria

• renal failure or Creatinine > 2mg/dl
• coagulopathy or hepatic insufficiency
• unstable vital sign under inotropic agents
• pregnancy
• metal implant or cardiac pacemaker
• major brain surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with essential hypertension	Brain MRI	Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Patient with primary aldosteronism	Brain MRI	Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

Primary Outcome Measures

Name	Time	Method
Cerebrovascular reactivity	During the brain MRI	Cerebrovascular reactivity measured by MRI under primary aldosteronism

Trial Locations

Locations (1)

Bei-Hu Branch, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan