The Long-term Effect of SAAE and Medical Treatment for Primary Aldosteronism

NCT05262660 | Unknown DMC

• 1 other identifier: SAAE-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective controlled trial, we aim to determine whether superselective adrenal artery embolization is superior to medical treatment for patients with PA who refuse surgery for medication. Patients age 18 to 75 years with hypertension will be screened for the presence of PA according to Endocrine Society Clinical Practice Guidelines. Patients with confirmed PA are counseled on the treatment option, including adrenalectomy. Those who opt to enroll in the study choice either SAAE or spironolactone (20-60mg daily) therapy (medical group). In both groups, if office blood pressure exceeds 140/90mmHg, amlodipine and terazosin will sequentially be added to the initial therapy form month 1 to year 3. The primary endpoint is the change in blood pressure, and the secondary end point is the change in biochemical outcomes. The Primary Aldosteronism Surgical Outcome criteria are used to classify clinical and biochemical outcomes as complete, partial, or absent success.

Conditions

Primary Aldosteronism

Keywords

Adrenal Arterial Embolization; mineralocorticoid receptor antagonist; clinical outcomes

Outcome Measures

Primary Outcomes (3)

• Clinical outcomes-Change from Baseline Systolic Blood Pressure

  Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication

  at 12 months

• Clinical outcomes-Change from Baseline Systolic Blood Pressure

  Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication

  at 24 months

• Clinical outcomes-Change from Baseline Systolic Blood Pressure

  Complete clinical success is defined as normotension without the aid of antihypertensive medication. Partial clinical success is defined as the same blood pressure as before treatment with less antihypertensive medication or a reduction in blood pressure with either the same amount or less antihypertensive medication. Absent clinical success is defined as unchanged or increased blood pressure with either the same amount or an increase in antihypertensive medication

  at 36 months

Secondary Outcomes (3)

• biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin

  at 12 months

• biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin

  at 24 months

• biochemical outcomes-Change from Baseline hypokalaemia and the aldosterone/plasma renin

  at 36 months

Study Arms (2)

SAAE group

Patients who were diagnosed with primary aldosteronism choice SAAE at our institution

MRA group

Patients who were diagnosed with primary aldosteronism choice medical treatment(mineralocorticoid receptor antagonists, MRA)) at our institution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.

You may qualify if:

• Clinical diagnosis of PA
• They refused medication treatment due to intolerance of side effects
• They had lateralization by adrenal venous sampling (AVS), and refused the adrenalectomy

You may not qualify if:

• History of serious contrast agent allergy
• Complication with severe liver diseases
• History of myocardial infarction and stent implantation within the past 3 months
• Renal insufficiency, with serum creatinine \>176 umo/L
• Pregnancy or lactation
• History of participation in another clinical trial in the past 3 months
• Any serious comorbidity

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Study Sites (1)

Yaqiong Zhou

Chengdu, Sichuan, 610500, China

Location

Related Publications (11)

• 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.

  PMID: 32852871 RESULT

• 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.

  PMID: 34398686 RESULT

• Vaidya A, Carey RM. Evolution of the Primary Aldosteronism Syndrome: Updating the Approach. J Clin Endocrinol Metab. 2020 Dec 1;105(12):3771-83. doi: 10.1210/clinem/dgaa606.

  PMID: 32865201 RESULT

• Bouhanick B, Delchier MC, Lagarde S, Boulestreau R, Conil C, Gosse P, Rousseau H, Lepage B, Olivier P, Papadopoulos P, Trillaud H, Cremer A; for the ADERADHTA group. Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study. J Hypertens. 2021 Apr 1;39(4):759-765. doi: 10.1097/HJH.0000000000002708.

  PMID: 33196558 RESULT

• 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.

  PMID: 23789675 RESULT

• Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

  PMID: 28576687 RESULT

• Kometani 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.

  PMID: 27041162 RESULT

• 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.

  PMID: 33605538 RESULT

• 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.

  PMID: 12676966 RESULT

• Zhou Y, Wang D, Jiang L, Ran F, Chen S, Zhou P, Wang P. Diagnostic accuracy of adrenal imaging for subtype diagnosis in primary aldosteronism: systematic review and meta-analysis. BMJ Open. 2020 Dec 31;10(12):e038489. doi: 10.1136/bmjopen-2020-038489.

  PMID: 33384386 RESULT

• Zhou Y, Liu S, Ji G, Yang C, Zhang L, Luo T, Huang F, Chen Z, Hou J, Wang P. Safety and efficacy of alcohol-mediated bilateral adrenal artery embolization in patients with idiopathic hyperaldosteronism: a 6-month follow-up of a randomized controlled trial. J Hum Hypertens. 2025 Jul;39(7):489-499. doi: 10.1038/s41371-025-01032-6. Epub 2025 Jun 4.

  PMID: 40468047 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

In-hospital data were obtained from the electronic medical record system (EMRS) at our institution. The 1-month ,6-month,12-month, 2-year and 3-year data were obtained from out-patient follow-up records in the EMRS, which included their complaints, antihypertensive regimens, office, and 24-hr mean blood pressures, biochemical parameters (plasma renin, aldosterone, and potassium), adverse events, and adrenal computerized tomography (only at 6 months). Clinical and biochemical outcomes were assessed based on Primary Aldosteronism Surgical Outcome (PASO) criteria and were classified as complete success, partial success, or absent success.

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Yanqiu Yang

  First Affiliated Hospital of Chengdu Medical College

  STUDY CHAIR

Central Study Contacts

Yaqiong Zhou

CONTACT

+8615184399329; 1273868593@qq.com

Peijian Wang

CONTACT

+861880718263; wpjmed@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: March 2, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)