Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

NCT03821571 | Unknown Phase 1

• 1 other identifier: 201811039RIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

Keywords

Hypertension,primary aldosteronism

Outcome Measures

Primary Outcomes (1)

• Cerebrovascular reactivity

  Cerebrovascular reactivity measured by MRI under primary aldosteronism

  During the brain MRI

Study Arms (2)

Patient with primary aldosteronism

EXPERIMENTAL

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

Diagnostic Test: Brain MRI

Patient with essential hypertension

ACTIVE COMPARATOR

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

Diagnostic Test: Brain MRI

Interventions

Brain MRI DIAGNOSTIC_TEST

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

Patient with essential hypertension; Patient with primary aldosteronism

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Bei-Hu Branch, National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

MeSH Terms

Conditions

Hypertension; Hyperaldosteronism

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Hsin-Hsi Tsai, MD

  Bei-Hu branch, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Hsi Tsai

CONTACT

+886 939916897; tsaihsinhsi@gmail.com

Bo-Ching Lee, MD

CONTACT

+886 972653442; bochinglee@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 30, 2019
• Study Start: January 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

TW (1)