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

NCT ID: NCT06228677

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 196 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2026-12-31

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adrenal Venous Sampling Group

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

Selective adrenal artery embolization

Intervention Type: PROCEDURE

Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Peripheral Venous Sampling Group

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

Selective adrenal artery embolization

Intervention Type: PROCEDURE

Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Interventions

Selective adrenal artery embolization

Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peijian Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chengdu Medical College

Locations

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peijian Wang, PhD

Role: CONTACT

wpjmed@aliyun.com

028-83016145 ext. +86

Sen Liu, MD

Role: CONTACT

463387160@qq.com

028-83016150 ext. +86

Facility Contacts

Peijian Wang, PhD

Role: primary

wpjmed@aliyun.com

028-83016145 ext. +86

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Other Identifiers

CCC-SAAE

Identifier Type: -

Identifier Source: org_study_id