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

NCT06228677 | Recruiting DMC

• 1 other identifier: CCC-SAAE
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resistant Hypertension; Secondary Hypertension; Secondary Hypertension to Endocrine Disorders; Primary Aldosteronism

Keywords

Primary Aldosteronism; Selective Adrenal Artery Embolization; catecholamine concentration; Adrenal Venous Blood; Blood Pressure Variability

Outcome Measures

Primary Outcomes (9)

• Invasive blood pressure

  Auxiliary check

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• 24-hour dynamic blood pressure

  Auxiliary check

  Selective adrenal artery embolization before 24 hours, after 24 hours

• Plasma Norepinephrine

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Plasma Adrenaline

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Plasma Dopamin

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Plasma Renin

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Plasma Aldosterone

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Serum sodium

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

• Serum potassium

  Biochemical indicators

  Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

Study Arms (2)

Adrenal Venous Sampling Group

Adrenal veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization

Procedure: Selective adrenal artery embolization

Peripheral Venous Sampling Group

Peripheral veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization

Procedure: Selective adrenal artery embolization

Interventions

Selective adrenal artery embolization PROCEDURE

Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Adrenal Venous Sampling Group; Peripheral Venous Sampling Group

Eligibility Criteria

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

Study Population

Hypertensive patients with a definite diagnosis of primary aldosteronism who agree to undergo percutaneous selective adrenal artery embolization.

You may qualify if:

• Age ≥18 years with no gender restrictions.
• 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.
• 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.
• Adrenal CT scan revealing adrenal hyperplasia, nodular formations, or no significant morphological deviations.
• Hypertension history surpassing a duration of 6 months.
• Prior to screening, patients or their lawful guardians must provide a signed informed consent, sanctioned by the ethics committee.

You may not qualify if:

• Patients diagnosed with primary hypertension or secondary hypertension attributed to other etiologies.
• Female participants who are presently pregnant, lactating, or with intentions to conceive within the forthcoming year.
• Presence of significant systemic diseases, with particular attention to hepatic and renal dysfunction.
• Pronounced allergic reaction to contrast agents.
• Any other serious systemic diseases with a life expectancy of less than 12 months.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 35445928 BACKGROUND

• 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.

  PMID: 36196469 BACKGROUND

• 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.

  PMID: 32210920 BACKGROUND

• 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.

  PMID: 29129575 BACKGROUND

• 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.

  PMID: 35067069 BACKGROUND

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 36813699 BACKGROUND

• 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.

  PMID: 33841329 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 36205513 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Peijian Wang, PhD

  First Affiliated Hospital of Chengdu Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peijian Wang, PhD

CONTACT

028-83016145; wpjmed@aliyun.com

Sen Liu, MD

CONTACT

028-83016150; 463387160@qq.com

Study Design

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

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: September 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year after the research is completed and the results are published.
• Access Criteria: Via the corresponding author's email

Locations

CN (1)