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Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism

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ClinicalTrials.gov Identifier: NCT03821571
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism Diagnostic Test: Brain MRI Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
Estimated Study Start Date : January 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Cerebrovascular reactivity [ Time Frame: During the brain MRI ]
    Cerebrovascular reactivity measured by MRI under primary aldosteronism



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821571


Contacts
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Contact: Hsin-Hsi Tsai +886 939916897 tsaihsinhsi@gmail.com
Contact: Bo-Ching Lee, MD +886 972653442 bochinglee@gmail.com

Locations
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Taiwan
Bei-Hu Branch, National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 10048
Contact: Hsin-Hsi Tsai, MD    +886 939916897    tsaihsinhsi@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Hsin-Hsi Tsai, MD Bei-Hu branch, National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03821571     History of Changes
Other Study ID Numbers: 201811039RIND
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Hypertension,primary aldosteronism

Additional relevant MeSH terms:
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Hyperaldosteronism
Cerebral Small Vessel Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases