Uncontrolled HypertensionPhase 3NCT03660397
Adrenal Artery Ablation for Uncontrolled Hypertension
A Phase 3 study testing Selective endovascular chemical ablation of adrenal gland and Traditional triple antihypertensive treatment in people with Uncontrolled Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Selective endovascular chemical ablation of adrenal gland and Traditional triple antihypertensive treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Jan 2020
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged between 30-60 years old.
- Patients with poorly controlled hypertension (office blood pressure ≥130/80 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks
- Positional blood aldosterone ≥100pg/ml.
- Informed consent signed and agreed to participate in this trial.
Who cannot join
- Hyperkalemia or hypokalemia.
- Secondary hypertension.
- History of depression, schizophrenia or vascular dementia.
- Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- Adrenergic insufficiency.
- Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
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- Acute infections, tumors and severe arrhythmias, psychiatric disorders,
- drugs or alcohol addicts.
- Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
- Fertile woman without contraceptives.
- Coagulation dysfunction.
- Pregnant women or lactating women.
- Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
- Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
- Allergy or any contraindications for the study drugs, contrast agents and alcohol.
- Refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Hongbo He, MD., 86-23-68757880, cqhehongbo@gmail.com
Zhiming Zhu, MD.
About this study
Official title: Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Uncontrolled Hypertension: A Randomized, Parallel, Active-controlled Clinical Trial
The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS 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 causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Selective endovascular chemical ablation of adrenal gland, Traditional triple antihypertensive treatment
- Keywords
- Uncontrolled Hypertension, Resistant hypertension, Aldosterone, Ablation, Adrenal Gland
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective endovascular chemical ablation of adrenal glandProcedure or surgery
Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group.
Traditional triple antihypertensive treatmentDrug
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Selective endovascular chemical ablation of adrenal gland after adrenal angiography. Receives: Procedure: Selective endovascular chemical ablation of adrenal gland; Drug: Traditional triple antihypertensive treatment |
| Control | Active comparator | No intervention, but treated with standard antihypertensive drugs Receives: Drug: Traditional triple antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed.
Measured: 24 weeks
Secondary outcomes (12)
Change of 24-h average systolic blood pressure compared with the baseline
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Measured: 24 weeks
Change of anti-hypertensive regimen measured at baseline and the end of the trial
Difference in the change of anti-hypertensive regimen between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measured at baseline and the end of the trial
Difference in the change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of home systolic and diastolic pressure between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of office systolic and diastolic pressure between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of blood electrolytes measured at baseline and the end of the trial
Difference in the change of blood electrolytes between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of plasma and urine adrenal hormones measured at baseline and the end of the trial
Difference in the change of plasma and urine adrenal hormones between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of plasma renin measured at baseline and the end of the trial
Difference in the change of plasma renin between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of liver enzymes measured at baseline and the end of the trial
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of kidney function measured at baseline and the end of the trial
Difference in the change of serum creatinine in umol/L between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of fasting blood glucose measured at baseline and the end of the trial
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of lipids profiles measured at baseline and the end of the trial
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group is to be analysed.
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 posted6 Sep 2018
- Study start1 Aug 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- NCT03660397
- Sponsor's protocol ID
- AAA-UHT
- Status last verified
- Sep 2018
- First submitted
- 7 Jun 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Uncontrolled Hypertension: A Randomized, Parallel, Active-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03660397
- Acronym / sponsor ID
- AAA-UHT
- Conditions
- Uncontrolled Hypertension
- Keywords
- Uncontrolled Hypertension, Resistant hypertension, Aldosterone, Ablation, Adrenal Gland
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 6 Sep 2018 (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.
The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS 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 causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Selective endovascular chemical ablation of adrenal gland, Drug: Traditional triple antihypertensive treatmentSelective endovascular chemical ablation of adrenal gland after adrenal angiography. |
| Control | Active comparator | Drug: Traditional triple antihypertensive treatmentNo intervention, but treated with standard antihypertensive drugs |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, aged between 30-60 years old.
- Patients with poorly controlled hypertension (office blood pressure ≥130/80 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks
- Positional blood aldosterone ≥100pg/ml.
- Informed consent signed and agreed to participate in this trial.
Key exclusion criteria (16 listed)
- Hyperkalemia or hypokalemia.
- Secondary hypertension.
- History of depression, schizophrenia or vascular dementia.
- Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- Adrenergic insufficiency.
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 |
|---|---|---|
| Selective endovascular chemical ablation of adrenal glandIntervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group. | Procedure or surgery | Intervention |
| Traditional triple antihypertensive treatmentirbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d | Drug | Control, Intervention |
Primary outcome
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed.
12 secondary outcomes
Change of 24-h average systolic blood pressure compared with the baseline
Time frame: 24 weeks
Change of anti-hypertensive regimen measured at baseline and the end of the trial
Time frame: 24 weeks
Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Change of blood electrolytes measured at baseline and the end of the trial
Time frame: 24 weeks
Change of plasma and urine adrenal hormones measured at baseline and the end of the trial
Time frame: 24 weeks
Change of plasma renin measured at baseline and the end of the trial
Time frame: 24 weeks
Change of liver enzymes measured at baseline and the end of the trial
Time frame: 24 weeks
Change of kidney function measured at baseline and the end of the trial
Time frame: 24 weeks
Change of fasting blood glucose measured at baseline and the end of the trial
Time frame: 24 weeks
Change of lipids profiles measured at baseline and the end of the trial
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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 third hospital affiliated to the Third Military Medical University
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selective endovascular chemical ablation of adrenal gland and Traditional triple antihypertensive treatment in people with Uncontrolled 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 4 inclusion and 16 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 6 Sep 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial (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 6 Sep 2018.