Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

National Taiwan University

Status and phase: Unknown; Phase 1

Conditions: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Treatments: Diagnostic Test: Brain MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03821571

201811039RIND

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patient with primary aldosteronism

Experimental group

Description:

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

Treatment:

Diagnostic Test: Brain MRI

Patient with essential hypertension

Active Comparator group

Description:

Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.

Treatment:

Diagnostic Test: Brain MRI