Essential HypertensionSAAE-RHNCT06568640
Superselective Adrenal Arterial Embolization for Refractory Hypertension: A Proof-of-Concept Study
A study testing Superselective adrenal arterial embolization in people with Essential Hypertension, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Superselective adrenal arterial embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years, no gender restrictions;
- Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
- Duration of hypertension greater than 6 months;
- Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
- Signed informed consent form.
Who cannot join
- Morning cortisol level < 4.3 µg/dL; estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; serum potassium level > 5.5 mmol/L;
- Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
- Pregnant women or those planning to conceive within the next year;
- Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
- Adrenal mass with a diameter exceeding 2 cm;
- Severe allergy to contrast agents;
- Patients enrolled or planning to participate in other clinical studies that could impact the results of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yifei the second affiliated hospital of Nanchang university, Doctor contact
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Yifei Dong, doctorate, +8613576007061, yf_dong66@126.com
About this study
Official title: Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
Read the detailed description
The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
- Conditions
- Essential Hypertension
- Being tested
- Superselective adrenal arterial embolization
- Keywords
- Essential hypertension, Superselective adrenal arterial embolization, Interventional therapy
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superselective adrenal arterial embolizationProcedure or surgery
Also called Adrenal artery ablation, catheter-based adrenal ablation, Transcatheter Arterial Ablation, Transarterial embolization
Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Interventional treatment group | Experimental | superselective adrenal arterial embolization Receives: Procedure: Superselective adrenal arterial embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mean systolic blood pressure
ambulatory blood pressure monitoring
Measured: 8 weeks after SAAE
Secondary outcomes (6)
Proportion of patients with non-refractory hypertension
Describe how many patients are converted from refractory hypertension to non-refractory hypertension
Measured: 8 weeks after SAAE
24-hour mean diastolic blood pressure
ambulatory blood pressure monitoring
Measured: 8 weeks after SAAE
Safety monitoring:Procedure-related complications
Procedure-related complications include but are not limited to the following: transient arrhythmia during the SAAE procedure, incidence of hypertensive encephalopathy; post-procedure complications such as pleural effusion, brachial artery pseudoaneurysm, brachial artery thrombosis, pancreatitis, and contrast-induced nephropathy.
Measured: up to 8 weeks
Safety monitoring:Adrenal-related hormones
Plasma aldosterone concentration, plasma renin activity, plasma cortisol concentration, corticotropin-releasing hormone level, blood catecholamine levels, sex hormone levels.
Measured: 8 weeks after SAAE
Safety monitoring:Kidney function
Estimated Glomerular Filtration Rate
Measured: 8 weeks after SAAE
Safety monitoring:Plasma electrolyte levels
Plasma potassium
Measured: 8 weeks after SAAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study design is a single-center, open-label, self-controlled, single-arm, prospective study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifei Dong, Second Affiliated Hospital of Nanchang University
- Investigators
- Yifei Dong, Doctor, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568640
- Sponsor's protocol ID
- IIT-2024-109
- Acronym
- SAAE-RH
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Exploration of the Safety and Efficacy of Superselective Adrenal Arterial Embolization in Patients With Essential Refractory Hypertension: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06568640
- Acronym / sponsor ID
- SAAE-RH / IIT-2024-109
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, Superselective adrenal arterial embolization, Interventional therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Aug 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.
The subjects of this study were patients with essential refractory hypertension. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
Detailed description
The subjects of this study were patients with essential refractory hypertension. The study design was a single-center, open-label, self-controlled, single-arm, prospective study. The purpose of this study is to evaluate the safety and efficacy of superselective adrenal arterial embolization (SAAE) in patients with primary refractory hypertension and to explore the possibility of SAAE in patients with primary refractory hypertension.After the subject completes the SAAE, an 8-week follow-up will be conducted to assess the safety and effectiveness of the SAAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is a single-center, open-label, self-controlled, single-arm, prospective study.
| Arm | Type | Receives |
|---|---|---|
| Interventional treatment group | Experimental | Procedure: Superselective adrenal arterial embolizationsuperselective adrenal arterial embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years, no gender restrictions;
- Primary refractory hypertension: Taking three antihypertensive drugs, including a - diuretic, with an average office systolic blood pressure ≥150 mmHg measured three times;
- Duration of hypertension greater than 6 months;
- Standing plasma aldosterone and renin activity not below the lower limit of the unit's reference range;
- Signed informed consent form.
Key exclusion criteria (7 listed)
- Morning cortisol level < 4.3 µg/dL; estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²; serum potassium level > 5.5 mmol/L;
- Type 1 diabetes, uncontrolled hyperthyroidism, malignant arrhythmias, malignant tumors, decompensated heart failure, severe liver dysfunction, severe hematological diseases, severe obstructive sleep apnea syndrome, history of myocardial infarction, syncope, cerebral hemorrhage, or cerebral infarction within the past 3 months;
- Pregnant women or those planning to conceive within the next year;
- Presence of other severe organic diseases that would make the patient unable to tolerate superselective adrenal arterial embolization;
- Adrenal mass with a diameter exceeding 2 cm;
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 |
|---|---|---|
| Superselective adrenal arterial embolizationAlso: Adrenal artery ablation, catheter-based adrenal ablation, Transcatheter Arterial Ablation, Transarterial embolizationSuperselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure. | Procedure or surgery | Interventional treatment group |
Primary outcome
24-hour mean systolic blood pressure
Time frame: 8 weeks after SAAE
ambulatory blood pressure monitoring
6 secondary outcomes
Proportion of patients with non-refractory hypertension
Time frame: 8 weeks after SAAE
24-hour mean diastolic blood pressure
Time frame: 8 weeks after SAAE
Safety monitoring:Procedure-related complications
Time frame: up to 8 weeks
Safety monitoring:Adrenal-related hormones
Time frame: 8 weeks after SAAE
Safety monitoring:Kidney function
Time frame: 8 weeks after SAAE
Safety monitoring:Plasma electrolyte levels
Time frame: 8 weeks after SAAE
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 23 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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.
Yifei the second affiliated hospital of Nanchang university, Doctor contact
Yifei Dong, Doctor principal investigator
Second Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superselective adrenal arterial embolization in people with Essential Hypertension, run by Second Affiliated Hospital of Nanchang 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Aug 2024. 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?
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 Yifei the second affiliated hospital of Nanchang university, Doctor ((0791)86209562, yf_dong66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour mean systolic blood pressure (time frame: 8 weeks after SAAE). 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 23 Aug 2024.