Resistant HypertensionNCT04345198
Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension
A study testing Adrenal Artery Ablation in people with Resistant Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Adrenal Artery Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 15 Oct 2019
- Phase
- Interventional
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age between 30-65 years old.
- Primary aldosteronism with resistant hypertension.
- Informed consent signed and agreed to participate in this trial.
Who cannot join
- Secodary hyertension due to other causes.
- History of depression,schizophrenia or vascular dementia .
- History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
Show all 9Show fewer
- Fertile woman without contraceptives.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
- Allergic to or have contraindication to the contrast agents and alcohol.
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Third Military Medical University
Chongqing, 400042
About this study
Official title: Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)
Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.
- Conditions
- Resistant Hypertension
- Being tested
- Adrenal Artery Ablation
- Keywords
- resistant hypertension; aldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adrenal Artery AblationProcedure or surgery
Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Intervension | Experimental | Adrenal artery ablation is performed in PA patients with resistant hypertension. Receives: Procedure: Adrenal Artery Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of office systolic blood ptressure
Change of office systolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Secondary outcomes (10)
Change of office dystolic blood pressure
Change of office dystolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Change of home systolic blood pressure
Change of home systolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Change of home diastolic blood pressure
Change of home diastolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Change of 24-h average systolic blood pressure
Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Change of 24-h average diastolic blood pressure
Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.
Measured: 24 weeks
Change of DDD of anti-hypertensive regimen
Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.
Measured: 24 weeks
Change of plasma adrenal hormones
Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.
Measured: 24 weeks
Change of plasma renin levels
Change of plasma renin levels compared with baseline after 24 weeks.
Measured: 24 weeks
Change of blood electrolytes
Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.
Measured: 24 weeks
Change of serum creatinine
Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Oct 2017
- Primary completion15 Apr 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345198
- Sponsor's protocol ID
- AAA-RHT
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)
- ClinicalTrials.gov ID
- NCT04345198
- Acronym / sponsor ID
- AAA-RHT
- Conditions
- Resistant Hypertension
- Keywords
- resistant hypertension; aldosteronism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 14 Apr 2020 (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.
Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervension | Experimental | Procedure: Adrenal Artery AblationAdrenal artery ablation is performed in PA patients with resistant hypertension. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age between 30-65 years old.
- Primary aldosteronism with resistant hypertension.
- Informed consent signed and agreed to participate in this trial.
Key exclusion criteria (9 listed)
- Secodary hyertension due to other causes.
- History of depression,schizophrenia or vascular dementia .
- History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
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 |
|---|---|---|
| Adrenal Artery AblationIntervention with adrenal artery ablation is performed in PA patients with resistant hypertension. | Procedure or surgery | Intervension |
Primary outcome
Change of office systolic blood ptressure
Time frame: 24 weeks
Change of office systolic blood pressure compared with baseline after 24 weeks.
10 secondary outcomes
Change of office dystolic blood pressure
Time frame: 24 weeks
Change of home systolic blood pressure
Time frame: 24 weeks
Change of home diastolic blood pressure
Time frame: 24 weeks
Change of 24-h average systolic blood pressure
Time frame: 24 weeks
Change of 24-h average diastolic blood pressure
Time frame: 24 weeks
Change of DDD of anti-hypertensive regimen
Time frame: 24 weeks
Change of plasma adrenal hormones
Time frame: 24 weeks
Change of plasma renin levels
Time frame: 24 weeks
Change of blood electrolytes
Time frame: 24 weeks
Change of serum creatinine
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Resistant Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adrenal Artery Ablation in people with Resistant Hypertension, run by Third Military Medical University at 1 site in China.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 14 Apr 2020. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of office systolic blood ptressure (time frame: 24 weeks). 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 14 Apr 2020.