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Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study (SAAE-BIH)

Primary Purpose

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Status

Enrolling by invitation

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

superselective adrenal arterial embolization

About this trial

This is an interventional treatment trial for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) focused on measuring primary aldosteronism, hypertension, superselective adrenal arterial embolization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Sites / Locations

the Second Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Superselective adrenal arterial embolization

Arm Description

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.

Outcomes

Primary Outcome Measures

Ambulatory blood pressure monitoring

24-hour ambulatory blood pressure monitor

Office blood pressure

sphygmomanometer

Secondary Outcome Measures

plasma aldosterone

reagent

potassium levels

reagent

adverse events

follow-up

Full Information

NCT ID

NCT05186675

First Posted

December 25, 2021

Last Updated

July 19, 2022

Sponsor

Second Affiliated Hospital of Nanchang University

1. Study Identification

Unique Protocol Identification Number

NCT05186675

Brief Title

Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study

Acronym

SAAE-BIH

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Enrolling by invitation

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Nanchang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Keywords

primary aldosteronism, hypertension, superselective adrenal arterial embolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Superselective adrenal arterial embolization

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

superselective adrenal arterial embolization

Intervention Description

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

Primary Outcome Measure Information:

Title

Ambulatory blood pressure monitoring

Description

24-hour ambulatory blood pressure monitor

Time Frame

one month after SAAE

Title

Office blood pressure

Description

sphygmomanometer

Time Frame

one month after SAAE

Secondary Outcome Measure Information:

Title

plasma aldosterone

Description

reagent

Time Frame

one month after SAAE

Title

potassium levels

Description

reagent

Time Frame

one month after SAAE

Title

adverse events

Description

follow-up

Time Frame

one month after SAAE

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (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. Exclusion Criteria: (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Yifei, Doctor

Organizational Affiliation

Second Affiliated Hospital of Nanchang University

Official's Role

Study Director

Facility Information:

Facility Name

the Second Affiliated Hospital of Nanchang University

City

Nanchang

State/Province

Jiagxi

ZIP/Postal Code

330006

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

33605538

Citation

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.

Results Reference

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PubMed Identifier

34398686

Citation

Zhao 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.

Results Reference

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PubMed Identifier

32852871

Citation

Zhang 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.

Results Reference

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PubMed Identifier

28385310

Citation

Monticone 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.

Results Reference

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PubMed Identifier

26934393

Citation

Funder 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.

Results Reference

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PubMed Identifier

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Citation

Inoue 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.

Results Reference

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PubMed Identifier

23789675

Citation

Fowler 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.

Results Reference

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PubMed Identifier

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Citation

Inoue 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.

Results Reference

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PubMed Identifier

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Citation

Hokotate 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.

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Citation

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Results Reference

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Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study

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