Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism Clinical Trial

Official title:

Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03821571
• Other study ID #: 201811039RIND
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 25, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: National Taiwan University Hospital
• Contact: Hsin-Hsi Tsai
• Phone: +886 939916897
• Email: tsaihsinhsi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
• Hyperaldosteronism

Intervention

Diagnostic Test:
• Brain MRI
Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.

Locations

Country	Name	City	State
Taiwan	Bei-Hu Branch, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular reactivity	Cerebrovascular reactivity measured by MRI under primary aldosteronism	During the brain MRI