Resistant HypertensionNCT06282107
Effectiveness and Safety of BiSAAE for Resistant Hypertension.
A study testing BiSAAE and traditional triple antihypertensive treatment in people with Resistant Hypertension, run by First Affiliated Hospital of Chengdu Medical College.
Trial summary
Hypertension is a common problem, affecting >1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. 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?
- BiSAAE 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
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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, aged between 30-65 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.
Show all 15Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension
Hypertension is a common problem, affecting >1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (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. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.
- Conditions
- Resistant Hypertension
- Being tested
- BiSAAE, traditional triple antihypertensive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiSAAEProcedure or surgery
SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines
traditional triple antihypertensive treatmentProcedure or surgery
traditional triple antihypertensive treatment
| Study group | Role | What they receive |
|---|---|---|
| Bilateral superselective adrenal arterial embolization | Experimental | Selectively injects 1.5-2.5 mL ethanol into bilateral adrenal artery to ablate part of the adrenal gland; irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d Receives: Procedure: BiSAAE |
| traditional triple antihypertensive treatment | Active comparator | irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d Receives: Procedure: 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
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: 12-month
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: 3-month
Secondary outcomes (48)
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 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: 3-month
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: 12-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 home systolic and diastolic pressure
Difference in the change of home systolic and diastolic pressure between the intervention and control group
Measured: 12-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: 3-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Measured: 6-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Measured: 12-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Measured: 3-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Measured: 6-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Measured: 12-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Measured: 3-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 aldosterone
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
Measured: 12-month
Change of plasma aldosterone
Difference in the change of plasma aldosterone (pg/mL) between the intervention and control group
Measured: 3-month
Change of plasma cortisol
Change of plasma cortisol
Measured: 6-month
Change of plasma cortisol
Change of plasma cortisol
Measured: 12-month
Change of plasma cortisol
Change of plasma cortisol
Measured: 3-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 plasma renin measured
Difference in the change of plasma renin (pg/ml) between the intervention and control group
Measured: 12-month
Change of plasma renin measured
Difference in the change of plasma renin (pg/ml) between the intervention and control group
Measured: 3-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 liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
Measured: 12-month
Change of liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group
Measured: 3-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 kidney function
Difference in the change of serum creatinine in umol/L between the intervention and control group
Measured: 12-month
Change of kidney function
Difference in the change of serum creatinine in umol/L between the intervention and control group
Measured: 3-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 fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
Measured: 3-month
Change of fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group
Measured: 12-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 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: 12-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: 3-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 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: 12-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: 3-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 urine microalbumin
Difference in the change of 24-h urine microalbumin (mg/L) between the intervention and control group
Measured: 12-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: 3-month
Change of 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 24-h urine creatinine
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
Measured: 12-month
Change of 24-h urine creatinine
Difference in the change of 24-h urine creatinine (umol/L) between the intervention and control group
Measured: 3-month
Change of echocardiography parameters (LVEF)
Change of echocardiography parameters (LVEF)
Measured: 6-month
Change of echocardiography parameters (LVEF)
Change of echocardiography parameters (LVEF)
Measured: 12-month
Change of echocardiography parameters (LVEF)
Change of echocardiography parameters (LVEF)
Measured: 3-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
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: 12-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: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282107
- Sponsor's protocol ID
- BiSAAE-RHT
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Luo T, Yang Y, Zhou Y, Hou J, Wang P. Unilateral chemical ablation of the adrenal gland lowers blood pressure and alleviates target organ damage in spontaneously hypertensive rats. Hypertens Res. 2023 Dec;46(12):2693-2704. doi: 10.1038/s41440-023-01444-2. Epub 2023 Oct 3.
PubMed 37789113Zhou Y, Wang X, Hou J, Wan J, Yang Y, Liu S, Luo T, Liu Q, Xue Q, Wang P. A controlled trial of percutaneous adrenal arterial embolization for hypertension in patients with idiopathic hyperaldosteronism. Hypertens Res. 2024 Feb;47(2):311-321. doi: 10.1038/s41440-023-01420-w. Epub 2023 Aug 29.
PubMed 37644179Zhou Y, Wang D, Liu Q, Hou J, Wang P. Case report: Percutaneous adrenal arterial embolization cures resistant hypertension. Front Cardiovasc Med. 2022 Oct 11;9:1013426. doi: 10.3389/fcvm.2022.1013426. eCollection 2022.
PubMed 36304542Zhou Y, Liu Q, Wang X, Wan J, Liu S, Luo T, He P, Hou J, Pu J, Wang D, Liang D, Yang Y, Wang P. Adrenal Ablation Versus Mineralocorticoid Receptor Antagonism for the Treatment of Primary Aldosteronism: A Single-Center Prospective Cohort Study. Am J Hypertens. 2022 Dec 8;35(12):1014-1023. doi: 10.1093/ajh/hpac105.
PubMed 36205513
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension
- ClinicalTrials.gov ID
- NCT06282107
- Acronym / sponsor ID
- BiSAAE-RHT
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (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 a common problem, affecting >1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (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. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral superselective adrenal arterial embolization | Experimental | Procedure: BiSAAESelectively injects 1.5-2.5 mL ethanol into bilateral adrenal artery to ablate part of the adrenal gland; irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
| traditional triple antihypertensive treatment | Active comparator | Procedure: traditional triple antihypertensive treatmentirbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d |
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, aged between 30-65 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 |
|---|---|---|
| BiSAAESAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into bilateral adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines | Procedure or surgery | Bilateral superselective adrenal arterial embolization |
| traditional triple antihypertensive treatmenttraditional triple antihypertensive treatment | Procedure or surgery | 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
Change of 24-h average systolic blood pressure
Time frame: 12-month
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
Change of 24-h average systolic blood pressure
Time frame: 3-month
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
48 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 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: 3-month
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: 12-month
Change of home systolic and diastolic pressure
Time frame: 6-month
Change of home systolic and diastolic pressure
Time frame: 12-month
Change of home systolic and diastolic pressure
Time frame: 3-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Time frame: 6-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Time frame: 12-month
Difference in the change of office systolic and diastolic pressure between the intervention and control group
Time frame: 3-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Time frame: 6-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Time frame: 12-month
Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group
Time frame: 3-month
Change of plasma aldosterone
Time frame: 6-month
Change of plasma aldosterone
Time frame: 12-month
Change of plasma aldosterone
Time frame: 3-month
Change of plasma cortisol
Time frame: 6-month
Change of plasma cortisol
Time frame: 12-month
Change of plasma cortisol
Time frame: 3-month
Change of plasma renin measured
Time frame: 6-month
Change of plasma renin measured
Time frame: 12-month
Change of plasma renin measured
Time frame: 3-month
Change of liver enzymes
Time frame: 6-month
Change of liver enzymes
Time frame: 12-month
Change of liver enzymes
Time frame: 3-month
Change of kidney function
Time frame: 6-month
Change of kidney function
Time frame: 12-month
Change of kidney function
Time frame: 3-month
Change of fasting blood glucose
Time frame: 6-month
Change of fasting blood glucose
Time frame: 3-month
Change of fasting blood glucose
Time frame: 12-month
Change of lipids profiles
Time frame: 6-month
Change of lipids profiles
Time frame: 12-month
Change of lipids profiles
Time frame: 3-month
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Time frame: 6-month
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Time frame: 12-month
Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)
Time frame: 3-month
Change of 24-h urine microalbumin
Time frame: 6-month
Change of 24-h urine microalbumin
Time frame: 12-month
Change of 24-h urine microalbumin
Time frame: 3-month
Change of 24-h urine creatinine
Time frame: 6-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 37789113Wang X, Luo T, Yang Y, Zhou Y, Hou J, Wang P. Unilateral chemical ablation of the adrenal gland lowers blood pressure and alleviates target organ damage in spontaneously hypertensive rats. Hypertens Res. 2023 Dec;46(12):2693-2704. doi: 10.1038/s41440-023-01444-2. Epub 2023 Oct 3.
- Background: PubMed 37644179Zhou Y, Wang X, Hou J, Wan J, Yang Y, Liu S, Luo T, Liu Q, Xue Q, Wang P. A controlled trial of percutaneous adrenal arterial embolization for hypertension in patients with idiopathic hyperaldosteronism. Hypertens Res. 2024 Feb;47(2):311-321. doi: 10.1038/s41440-023-01420-w. Epub 2023 Aug 29.
- Background: PubMed 36304542Zhou Y, Wang D, Liu Q, Hou J, Wang P. Case report: Percutaneous adrenal arterial embolization cures resistant hypertension. Front Cardiovasc Med. 2022 Oct 11;9:1013426. doi: 10.3389/fcvm.2022.1013426. eCollection 2022.
- Background: PubMed 36205513Zhou Y, Liu Q, Wang X, Wan J, Liu S, Luo T, He P, Hou J, Pu J, Wang D, Liang D, Yang Y, Wang P. Adrenal Ablation Versus Mineralocorticoid Receptor Antagonism for the Treatment of Primary Aldosteronism: A Single-Center Prospective Cohort Study. Am J Hypertens. 2022 Dec 8;35(12):1014-1023. doi: 10.1093/ajh/hpac105.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing BiSAAE 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: opening soon, as of the sponsor's last update on 28 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaqiong Zhou (+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). The study lists 3 primary outcomes in all. 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 NCT06282107, which also lists 4 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 28 Feb 2024.