Evaluation of Cerebral Small Vessel Disease in Patient With Primary AldosteronismPhase 1NCT03821571
Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
A Phase 1 study testing Brain MRI in people with Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
- What is being tested?
- Brain MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2019to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 20-90 years-old
- patient with primary aldosteronism or healthy control
- consciousness clear
- willing to receive brain MRI
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site
Bei-Hu Branch, National Taiwan University Hospital
Taipei, 10048
Hsin-Hsi Tsai, MD, +886 939916897, tsaihsinhsi@gmail.com
About this study
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.
- Being tested
- Brain MRI
- Keywords
- Hypertension,primary aldosteronism
- Medical subject headings
- Hypertension, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDiagnostic test
Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.
| Study group | Role | What they receive |
|---|---|---|
| Patient with primary aldosteronism | Experimental | Brain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed. Receives: 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. Receives: Diagnostic Test: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular reactivity
Cerebrovascular reactivity measured by MRI under primary aldosteronism
Measured: During the brain MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start25 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Cerebral Small Vessel Disease in Patient With Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsin-Hsi Tsai, MD, Principal investigator, Bei-Hu branch, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821571
- Sponsor's protocol ID
- 201811039RIND
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT03821571
- Acronym / sponsor ID
- 201811039RIND
- Keywords
- Hypertension,primary aldosteronism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with primary aldosteronism | Experimental | Diagnostic Test: Brain MRIBrain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed. |
| Patient with essential hypertension | Active comparator | Diagnostic Test: Brain MRIBrain MRI with T1WI, T2WI, FLAIR, thin-sliced T1WI, DWI, TOF, and blood sensitive sequence (SWI) will be performed. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 20-90 years-old
- patient with primary aldosteronism or healthy control
- consciousness clear
- willing to receive brain MRI
Key exclusion criteria (6 listed)
- renal failure or Creatinine > 2mg/dl
- coagulopathy or hepatic insufficiency
- unstable vital sign under inotropic agents
- pregnancy
- metal implant or cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients. | Diagnostic test | Patient with essential hypertension, Patient with primary aldosteronism |
Primary outcome
Cerebrovascular reactivity
Time frame: During the brain MRI
Cerebrovascular reactivity measured by MRI under primary aldosteronism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsin-Hsi Tsai, MD principal investigator
Bei-Hu branch, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brain MRI in people with Evaluation of Cerebral Small Vessel Disease in Patient With Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Hsi Tsai (+886 939916897, tsaihsinhsi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular reactivity (time frame: During the brain MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.