Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)SAAE-BIHNCT05186675
Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study
A study testing superselective adrenal arterial embolization in people with Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) Age 18-60 years old, regardless of gender; (2) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral idiopathic aldosteronism was confirmed by adrenal venous sampling; (3) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring：whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (4) Adrenal CT showed adrenal hyperplasia, nodules or no obvious morphological abnormalities； (5) The course of hypertension is more than 6 months； (6) The patient or his legal representative shall sign the written informed consent approved by the ethics committee before screening.
Who cannot join
- (1) Primary hypertension or secondary hypertension with other causes; (2) A woman who is pregnant or lactating, or has a birth plan in the next year; (3) There are serious organic diseases, especially liver and kidney dysfunction; (4) Severe allergy to contrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6) Adrenal CT showed adenoma. (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiagxi, 330006
About this study
Official title: Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study
The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Hence, an alternative therapy is needed in such cases. We hypothesized that superselective adrenal artery embolization (SAAE) could be a suitable alternative approach. To our knowledge, SAAE has so far not been applied to treat bilateral IHA. This study aimed to evaluate the efficacy and safety of SAAE in the treatment of PA patients with bilateral IHA.
Read the detailed description
Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for more than 5% of the general hypertensive cases and 17-20% of resistant hypertension.The most common PA subtype is bilateral idiopathic hyperaldosteronism (IHA), and medical therapy with mineralocorticoid receptor antagonists (MRAs) is recommended for these patients.The clinical studies showed that PA patients had more cardiovascular events than patients with essential hypertension independent of blood pressure, and PA patients with higher plasma aldosterone levels had a higher cardiovascular risk. However, MRAs are unable to reduce the level of plasma aldosterone. Moreover, the undesirable adverse effects of MRAs also limit their wide application, particularly in men.
Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.
- Being tested
- superselective adrenal arterial embolization
- Keywords
- primary aldosteronism, hypertension, superselective adrenal arterial embolization
- Medical subject headings
- Hyperaldosteronism, 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
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 |
|---|---|---|
| Superselective adrenal arterial embolization | Experimental | For patients with bilateral idiopathic hyperaldosteronism confirmed by adrenal venous sampling, Superselective adrenal arterial embolization（SAAE）shall be given according to the patient's wishes. The blood pressure, plasma aldosterone and potassium levels, and adverse events were assessed after SAAE. The primary endpoint was the change in home blood pressure at one months, compared with baseline. Receives: Procedure: superselective adrenal arterial embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitoring
24-hour ambulatory blood pressure monitor
Measured: one month after SAAE
Office blood pressure
sphygmomanometer
Measured: one month after SAAE
Secondary outcomes (3)
plasma aldosterone
reagent
Measured: one month after SAAE
potassium levels
reagent
Measured: one month after SAAE
adverse events
follow-up
Measured: one month after SAAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)Studies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Yifei, Doctor, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186675
- Sponsor's protocol ID
- 2021NDEFY21
- Acronym
- SAAE-BIH
- Status last verified
- Dec 2021
- First submitted
- 25 Dec 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: From January 2022 to December 2022, 50 cases of bilateral idiopathic aldosteronism were selected; 2023.1-2023.2 complete the follow-up of all enrolled patients; 2023.3-2023.6 statistical data, writing and publishing academic papers
Publications
Dong 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 33605538Zhao 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 34398686Zhang H, Li Q, Liu X, Zhao Z, He H, Sun F, Hong Y, Zhou X, Li Y, Shen R, Bu X, Yan Z, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Adrenal artery ablation for primary aldosteronism without apparent aldosteronoma: An efficacy and safety, proof-of-principle trial. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1618-1626. doi: 10.1111/jch.13960. Epub 2020 Aug 27.
PubMed 32852871Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
PubMed 28385310Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
PubMed 26934393Inoue H, Nakajo M, Miyazono N, Kanetsuki I, Miyake S, Hokotate H, Iida K, Niwatsukino H, Matsumoto Y, Tanaka D, et al. Treatment of aldosteronoma with superselective intraarterial injection of absolute ethanol. Nihon Igaku Hoshasen Gakkai Zasshi. 1994 Feb 25;54(2):154-62. No abstract available.
PubMed 8121780Fowler AM, Burda JF, Kim SK. Adrenal artery embolization: anatomy, indications, and technical considerations. AJR Am J Roentgenol. 2013 Jul;201(1):190-201. doi: 10.2214/AJR.12.9507.
PubMed 23789675Inoue H, Nakajo M, Miyazono N, Nishida H, Ueno K, Hokotate H. Transcatheter arterial ablation of aldosteronomas with high-concentration ethanol: preliminary and long-term results. AJR Am J Roentgenol. 1997 May;168(5):1241-5. doi: 10.2214/ajr.168.5.9129420.
PubMed 9129420Hokotate H, Inoue H, Baba Y, Tsuchimochi S, Nakajo M. Aldosteronomas: experience with superselective adrenal arterial embolization in 33 cases. Radiology. 2003 May;227(2):401-6. doi: 10.1148/radiol.2272011798. Epub 2003 Apr 3.
PubMed 12676966Kometani M, Yoneda T, Demura M, Karashima S, Mori S, Oe M, Sawamura T, Okuda R, Yamagishi M, Takeda Y. The Long-term Effect of Adrenal Arterial Embolization for Unilateral Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile. Intern Med. 2016;55(7):769-73. doi: 10.2169/internalmedicine.55.5196. Epub 2016 Apr 1.
PubMed 27041162
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Percutaneous Superselective Adrenal Arterial Embolization in the Treatment of Primary Aldosteronism With Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05186675
- Acronym / sponsor ID
- SAAE-BIH / 2021NDEFY21
- Keywords
- primary aldosteronism, hypertension, superselective adrenal arterial embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jan 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.
The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Hence, an alternative therapy is needed in such cases. We hypothesized that superselective adrenal artery embolization (SAAE) could be a suitable alternative approach. To our knowledge, SAAE has so far not been applied to treat bilateral IHA. This study aimed to evaluate the efficacy and safety of SAAE in the treatment of PA patients with bilateral IHA.
Detailed description
Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for more than 5% of the general hypertensive cases and 17-20% of resistant hypertension.The most common PA subtype is bilateral idiopathic hyperaldosteronism (IHA), and medical therapy with mineralocorticoid receptor antagonists (MRAs) is recommended for these patients.The clinical studies showed that PA patients had more cardiovascular events than patients with essential hypertension independent of blood pressure, and PA patients with higher plasma aldosterone levels had a higher cardiovascular risk. However, MRAs are unable to reduce the level of plasma aldosterone. Moreover, the undesirable adverse effects of MRAs also limit their wide application, particularly in men.
Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Superselective adrenal arterial embolization | Experimental | Procedure: superselective adrenal arterial embolizationFor patients with bilateral idiopathic hyperaldosteronism confirmed by adrenal venous sampling, Superselective adrenal arterial embolization（SAAE）shall be given according to the patient's wishes. The blood pressure, plasma aldosterone and potassium levels, and adverse events were assessed after SAAE. The primary endpoint was the change in home blood pressure at one months, compared with baseline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) Age 18-60 years old, regardless of gender; (2) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral idiopathic aldosteronism was confirmed by adrenal venous sampling; (3) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring：whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (4) Adrenal CT showed adrenal hyperplasia, nodules or no obvious morphological abnormalities； (5) The course of hypertension is more than 6 months； (6) The patient or his legal representative shall sign the written informed consent approved by the ethics committee before screening.
Key exclusion criteria (1 listed)
- (1) Primary hypertension or secondary hypertension with other causes; (2) A woman who is pregnant or lactating, or has a birth plan in the next year; (3) There are serious organic diseases, especially liver and kidney dysfunction; (4) Severe allergy to contrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6) Adrenal CT showed adenoma. (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
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 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 | Superselective adrenal arterial embolization |
Primary outcome
Ambulatory blood pressure monitoring
Time frame: one month after SAAE
24-hour ambulatory blood pressure monitor
Office blood pressure
Time frame: one month after SAAE
sphygmomanometer
3 secondary outcomes
plasma aldosterone
Time frame: one month after SAAE
potassium levels
Time frame: one month after SAAE
adverse events
Time frame: one month after SAAE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: 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.
- Background: 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.
- Background: PubMed 32852871Zhang H, Li Q, Liu X, Zhao Z, He H, Sun F, Hong Y, Zhou X, Li Y, Shen R, Bu X, Yan Z, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Adrenal artery ablation for primary aldosteronism without apparent aldosteronoma: An efficacy and safety, proof-of-principle trial. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1618-1626. doi: 10.1111/jch.13960. Epub 2020 Aug 27.
- Background: PubMed 28385310Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.
- Background: PubMed 26934393Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
- Background: PubMed 8121780Inoue H, Nakajo M, Miyazono N, Kanetsuki I, Miyake S, Hokotate H, Iida K, Niwatsukino H, Matsumoto Y, Tanaka D, et al. Treatment of aldosteronoma with superselective intraarterial injection of absolute ethanol. Nihon Igaku Hoshasen Gakkai Zasshi. 1994 Feb 25;54(2):154-62. No abstract available.
- Background: PubMed 23789675Fowler AM, Burda JF, Kim SK. Adrenal artery embolization: anatomy, indications, and technical considerations. AJR Am J Roentgenol. 2013 Jul;201(1):190-201. doi: 10.2214/AJR.12.9507.
- Background: PubMed 9129420Inoue H, Nakajo M, Miyazono N, Nishida H, Ueno K, Hokotate H. Transcatheter arterial ablation of aldosteronomas with high-concentration ethanol: preliminary and long-term results. AJR Am J Roentgenol. 1997 May;168(5):1241-5. doi: 10.2214/ajr.168.5.9129420.
- Background: PubMed 12676966Hokotate H, Inoue H, Baba Y, Tsuchimochi S, Nakajo M. Aldosteronomas: experience with superselective adrenal arterial embolization in 33 cases. Radiology. 2003 May;227(2):401-6. doi: 10.1148/radiol.2272011798. Epub 2003 Apr 3.
- Background: PubMed 27041162Kometani M, Yoneda T, Demura M, Karashima S, Mori S, Oe M, Sawamura T, Okuda R, Yamagishi M, Takeda Y. The Long-term Effect of Adrenal Arterial Embolization for Unilateral Primary Aldosteronism on Cardiorenovascular Protection, Blood Pressure, and the Endocrinological Profile. Intern Med. 2016;55(7):769-73. doi: 10.2169/internalmedicine.55.5196. Epub 2016 Apr 1.
- Individual participant dataSharing planned: No. From January 2022 to December 2022, 50 cases of bilateral idiopathic aldosteronism were selected; 2023.1-2023.2 complete the follow-up of all enrolled patients; 2023.3-2023.6 statistical data, writing and publishing academic papers
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.
Dong Yifei, Doctor study director
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 Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral), 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 1 inclusion and 1 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 21 Jul 2022. 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?
Results are not available in the source record.
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?
Ambulatory blood pressure monitoring (time frame: one month after SAAE). The study lists 2 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 NCT05186675, which also lists 10 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 21 Jul 2022.