Resistant HypertensionNCT05552300
Superselective Adrenal Arterial Embolization for Resistant Hypertension
A study testing SAAE and traditional triple antihypertensive treatment in people with Resistant Hypertension, run by First Affiliated Hospital of Chengdu Medical College.
Trial summary
Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- SAAE 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
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Mar 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged between 18-65 years old.
- Patients with resist hypertension (office systolic blood pressure ≥140 mmHg, and/or office diastolic blood pressure ≥90 mmHg, and/or 24-h average systolic blood pressure ≥130 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 4 weeks.
- Informed consent signed and agreed to participate in this trial.
Who cannot join
- Secondary hypertension
- Adrenergic insufficiency.
- adrenocortical insufficiency
- Renal failure eGFR<60 mL/min/1.73 m2
- 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.
- Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
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- 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.
- History of depression, schizophrenia or vascular dementia.
- Refused to sign informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial
Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. It is not uncommon, being identified in 10 to 30% of hypertensive patients and it is known to be a risk factor for cardiovascular (CV) events, including stroke, myocardial infarction (MI), heart failure (HF), and CV mortality, as well as adverse renal events,including chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system can play a pathogenic role in triggering and sustaining RH. SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Therefore, SAAE is a minimally invasive procedure that might be used as an alternative strategy to antihypertensive drugs or reduce the intensity of antihypertensive drugs.
Read the detailed description
Not Provided
- Conditions
- Resistant Hypertension
- Being tested
- SAAE, traditional triple antihypertensive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAAEProcedure or surgery
SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines
traditional triple antihypertensive treatmentDrug
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Superselective adrenal arterial embolization | Experimental | Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland
Interventions:
Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment Receives: Procedure: SAAE; Drug: traditional triple antihypertensive treatment |
| Traditional triple antihypertensive treatment | Active comparator | No intervention, but treated with traditional triple antihypertensive treatment 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
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
Measured: 6-month
Secondary outcomes (17)
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
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
Measured: 6-month
Change of the number of antihypertensive medications
Difference in the change of the number of antihypertensive medications between the intervention and control group
Measured: 6-month
Change of home systolic and diastolic pressure
Difference in the change of home systolic and diastolic pressure between the intervention and control group
Measured: 6-month
Change of office systolic and diastolic pressure
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Measured: 6-month
Change of blood electrolytes (K+, Na +)
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Measured: 6-month
Change of plasma aldosterone
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
Measured: 6-month
Change of plasma cortisol
Difference in the change of plasma cortisol (nmol/L) between the intervention and control group
Measured: 6-month
Change of plasma renin measured
Difference in the change of plasma renin (pg/ml) between the intervention and control group
Measured: 6-month
Change of liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
Measured: 6-month
Change of kidney function
Difference in the change of serum creatinine in umol/L between the intervention and control group
Measured: 6-month
Change of fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
Measured: 6-month
Change of lipids profiles
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group
Measured: 6-month
Change of 24-h urine microalbumin
Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group
Measured: 6-month
Change of 24-h 24-h urine creatinine
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
Measured: 6-month
Change of echocardiography parameters (LVEF)
Difference in the change of cardiac parameters assessed by echocardiography LVEF (%) between the intervention and control group
Measured: 6-month
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Difference in the change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre[mm]) between the intervention and control group
Measured: 6-month
Change of carotid intima-media thickness
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peijian Wang, Study chair, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552300
- Sponsor's protocol ID
- SAAE-RHT
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455.
PubMed 35268545Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.
PubMed 33605538Giurazza F, Corvino F, Silvestre M, Cangiano G, Cavaglia E, Amodio F, De Magistris G, Frauenfelder G, Niola R. Adrenal glands hemorrhages: embolization in acute setting. Gland Surg. 2019 Apr;8(2):115-122. doi: 10.21037/gs.2018.10.06.
PubMed 31183321Zhou Q, Liu X, Zhang H, Zhao Z, Li Q, He H, Zhu Z, Yan Z. Adrenal Artery Ablation for the Treatment of Hypercortisolism Based on Adrenal Venous Sampling: A Potential Therapeutic Strategy. Diabetes Metab Syndr Obes. 2020 Oct 6;13:3519-3525. doi: 10.2147/DMSO.S262092. eCollection 2020.
PubMed 33116703Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.
PubMed 34398686
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05552300
- Acronym / sponsor ID
- SAAE-RHT
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Sep 2022 (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.
Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. It is not uncommon, being identified in 10 to 30% of hypertensive patients and it is known to be a risk factor for cardiovascular (CV) events, including stroke, myocardial infarction (MI), heart failure (HF), and CV mortality, as well as adverse renal events,including chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system can play a pathogenic role in triggering and sustaining RH. SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Therefore, SAAE is a minimally invasive procedure that might be used as an alternative strategy to antihypertensive drugs or reduce the intensity of antihypertensive drugs.
Detailed description
Not Provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superselective adrenal arterial embolization | Experimental | Procedure: SAAE, Drug: traditional triple antihypertensive treatmentSelectively injects ethanol into adrenal artery to ablate part of the adrenal gland Interventions: Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment |
| Traditional triple antihypertensive treatment | Active comparator | Drug: traditional triple antihypertensive treatmentNo intervention, but treated with traditional triple antihypertensive treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged between 18-65 years old.
- Patients with resist hypertension (office systolic blood pressure ≥140 mmHg, and/or office diastolic blood pressure ≥90 mmHg, and/or 24-h average systolic blood pressure ≥130 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 4 weeks.
- Informed consent signed and agreed to participate in this trial.
Key exclusion criteria (15 listed)
- Secondary hypertension
- Adrenergic insufficiency.
- adrenocortical insufficiency
- Renal failure eGFR<60 mL/min/1.73 m2
- 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.
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 |
|---|---|---|
| SAAESAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines | Procedure or surgery | Superselective adrenal arterial embolization |
| traditional triple antihypertensive treatmentirbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d | Drug | Superselective adrenal arterial embolization, Traditional triple antihypertensive treatment |
Primary outcome
Change of 24-h average systolic blood pressure
Time frame: 6-month
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
17 secondary outcomes
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
Time frame: 6-month
Change of the number of antihypertensive medications
Time frame: 6-month
Change of home systolic and diastolic pressure
Time frame: 6-month
Change of office systolic and diastolic pressure
Time frame: 6-month
Change of blood electrolytes (K+, Na +)
Time frame: 6-month
Change of plasma aldosterone
Time frame: 6-month
Change of plasma cortisol
Time frame: 6-month
Change of plasma renin measured
Time frame: 6-month
Change of liver enzymes
Time frame: 6-month
Change of kidney function
Time frame: 6-month
Change of fasting blood glucose
Time frame: 6-month
Change of lipids profiles
Time frame: 6-month
Change of 24-h urine microalbumin
Time frame: 6-month
Change of 24-h 24-h urine creatinine
Time frame: 6-month
Change of echocardiography parameters (LVEF)
Time frame: 6-month
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Time frame: 6-month
Change of carotid intima-media thickness
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Results publication: PubMed 35268545Bourque G, Hiremath S. Rethinking Resistant Hypertension. J Clin Med. 2022 Mar 7;11(5):1455. doi: 10.3390/jcm11051455.
- Results publication: PubMed 33605538Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.
- Results publication: PubMed 31183321Giurazza F, Corvino F, Silvestre M, Cangiano G, Cavaglia E, Amodio F, De Magistris G, Frauenfelder G, Niola R. Adrenal glands hemorrhages: embolization in acute setting. Gland Surg. 2019 Apr;8(2):115-122. doi: 10.21037/gs.2018.10.06.
- Results publication: PubMed 33116703Zhou Q, Liu X, Zhang H, Zhao Z, Li Q, He H, Zhu Z, Yan Z. Adrenal Artery Ablation for the Treatment of Hypercortisolism Based on Adrenal Venous Sampling: A Potential Therapeutic Strategy. Diabetes Metab Syndr Obes. 2020 Oct 6;13:3519-3525. doi: 10.2147/DMSO.S262092. eCollection 2020.
- Results publication: PubMed 34398686Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.
- Individual participant dataSharing planned: No
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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.
Peijian Wang study chair
Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College
Questions about this trial
What is this clinical trial studying?
A study testing SAAE and traditional triple antihypertensive treatment in people with Resistant Hypertension, run by First Affiliated Hospital of Chengdu Medical College.
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 15 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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaqiong Zhou, MD (+8615184399329, 1273868593@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-h average systolic blood pressure (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552300, which also lists 5 linked publications.
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 23 Sep 2022; AzTrials last refreshed its copy on 4 Nov 2026.