Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

January 28, 2019 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Bei-Hu Branch, National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with primary aldosteronism
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Diagnostic test: Brain MRI
Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.
Active Comparator: Patient with essential hypertension
Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed.
Diagnostic test: Brain MRI
Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebrovascular reactivity
Time Frame: During the brain MRI
Cerebrovascular reactivity measured by MRI under primary aldosteronism
During the brain MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hsin-Hsi Tsai, MD, Bei-Hu Branch, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 25, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201811039RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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