Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization

Primary Aldosteronism Clinical Trial

Official title:

Comparison of Catecholamine Concentrations in Adrenal Venous Blood and Peripheral Venous Blood During Percutaneous Selective Adrenal Artery Embolization in Hypertensive Patients With Primary Aldosteronism: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228677
• Other study ID #: CCC-SAAE
• Status: Recruiting
• Start date: September 18, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Peijian Wang, PhD
• Phone: 028-83016145
• Email: wpjmed[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the relationship between perioperative blood pressure and catecholamine concentrations in adrenal venous blood and peripheral venous blood in hypertensive patients with primary aldosteronism (PA) who underwent percutaneous selective adrenal artery embolization (SAAE). In order to elucidate the related phenomena and possible mechanisms of blood pressure fluctuations caused by SAAE treatment in hypertensive patients with PA.

Description:

Percutaneous selective adrenal artery embolization (SAAE) is a minimally invasive interventional procedure that allows for necrosis of diseased adrenal glands by selectively embolizing the adrenal arteries supplying the lesion using an embolic agent to block the overproduction of aldosterone, and has been used as a treatment for PA as a minimally invasive alternative. However, it is of concern that in our team's SAAE practice, we have found that some patients with PA experience a dramatic increase in blood pressure during surgery, even exceeding 220/130 mmHg, yet some patients do not experience significant fluctuations in blood pressure. The perioperative risk is undoubtedly significantly increased for patients with high blood pressure fluctuations. What are the reasons for this discrepancy phenomenon? Therefore, the present study was designed to synchronize adrenal vein blood collection in PA hypertensive patients undergoing SAAE, and to compare the perioperative adrenal vein blood and peripheral venous blood catecholamine concentrations, with a view to discovering the patterns and possible causes of blood pressure fluctuations, hormone level changes, and other phenotypic changes, and elucidating the possible mechanisms of blood pressure fluctuations triggered by SAAE treatment of PA hypertension, in order to provide an evidence-based basis for minimally invasive interventional therapy for PA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years with no gender restrictions.

2. Adherence to the "Primary Aldosteronism" Diagnosis and Treatment Guidelines, confirmed diagnosis of primary aldosteronism following rigorous drug washout, and identification as either aldosteronoma or idiopathic aldosteronism via adrenal vein blood sampling.

3. Blood pressure metrics that satisfy any of the subsequent conditions: a) Clinic-recorded blood pressure =140/90mmHg; b) 24-hour ambulatory blood pressure monitoring results displaying average blood pressure >130/80 mmHg or daytime readings >135/85 mmHg.

4. Adrenal CT scan revealing adrenal hyperplasia, nodular formations, or no significant morphological deviations.

5. Hypertension history surpassing a duration of 6 months.

6. Prior to screening, patients or their lawful guardians must provide a signed informed consent, sanctioned by the ethics committee.

Exclusion Criteria:

1. Patients diagnosed with primary hypertension or secondary hypertension attributed to other etiologies.

2. Female participants who are presently pregnant, lactating, or with intentions to conceive within the forthcoming year.

3. Presence of significant systemic diseases, with particular attention to hepatic and renal dysfunction.

4. Pronounced allergic reaction to contrast agents.

5. Any other serious systemic diseases with a life expectancy of less than 12 months.

6. Participants concurrently enrolled or expressing interest to participate in other clinical trials, the outcomes of which could potentially influence the results of the current study.

7. The researcher's discretion deems the subject inappropriate for inclusion in the study for any given reason.

Related Conditions & MeSH terms

• Endocrine System Diseases
• Hyperaldosteronism
• Hypertension
• Neoplasm Metastasis
• Primary Aldosteronism
• Resistant Hypertension
• Secondary Hypertension

Intervention

Procedure:
• Selective adrenal artery embolization
Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View 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. — View Citation

Funder JW, Carey RM. Primary Aldosteronism: Where Are We Now? Where to From Here? Hypertension. 2022 Apr;79(4):726-735. doi: 10.1161/HYPERTENSIONAHA.121.18761. Epub 2022 Jan 24. — View 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. — View Citation

Huang WC, Lin YH, Wu VC, Chen CH, Siddique S, Chia YC, Tay JC, Sogunuru G, Cheng HM, Kario K. Who should be screened for primary aldosteronism? A comprehensive review of current evidence. J Clin Hypertens (Greenwich). 2022 Sep;24(9):1194-1203. doi: 10.1111/jch.14558. — View Citation

Lu YC, Liu KL, Wu VC, Wang SM, Lin YH, Chueh SJ, Wu KD, Su YR, Huang KH; TAIPAI Study Group. Unilateral adrenalectomy in bilateral adrenal hyperplasia with primary aldosteronism. J Formos Med Assoc. 2023 May;122(5):393-399. doi: 10.1016/j.jfma.2022.12.015. Epub 2023 Feb 20. — View Citation

Meng Z, Dai Z, Huang K, Xu C, Zhang YG, Zheng H, Liu TZ. Long-Term Mortality for Patients of Primary Aldosteronism Compared With Essential Hypertension: A Systematic Review and Meta-Analysis. Front Endocrinol (Lausanne). 2020 Mar 10;11:121. doi: 10.3389/fendo.2020.00121. eCollection 2020. — View Citation

Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9. — View Citation

Stavropoulos K, Imprialos KP, Patoulias D, Katsimardou A, Doumas M. Impact of Primary Aldosteronism in Resistant Hypertension. Curr Hypertens Rep. 2022 Aug;24(8):285-294. doi: 10.1007/s11906-022-01190-9. Epub 2022 Apr 21. — View Citation

Tezuka Y, Turcu AF. Real-World Effectiveness of Mineralocorticoid Receptor Antagonists in Primary Aldosteronism. Front Endocrinol (Lausanne). 2021 Mar 26;12:625457. doi: 10.3389/fendo.2021.625457. eCollection 2021. — View 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. — View Citation

Zhou 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive blood pressure	Auxiliary check	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	24-hour dynamic blood pressure	Auxiliary check	Selective adrenal artery embolization before 24 hours, after 24 hours
Primary	Plasma Norepinephrine	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Plasma Adrenaline	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Plasma Dopamin	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Plasma Renin	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Plasma Aldosterone	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Serum sodium	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes
Primary	Serum potassium	Biochemical indicators	Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes