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

January 19, 2024 updated by: First Affiliated Hospital of Chengdu Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610500
        • Recruiting
        • The First Affiliated Hospital of Chengdu Medical College
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adrenal Venous Sampling Group
Adrenal veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Procedure: Selective adrenal artery embolization
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
Procedure: Selective adrenal artery embolization
Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chengdu Medical College

Investigators

  • Principal Investigator: Peijian Wang, PhD, First Affiliated Hospital of Chengdu Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC-SAAE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Shared with the researchers' consent

IPD Sharing Time Frame

1 year after the research is completed and the results are published.

IPD Sharing Access Criteria

Via the corresponding author's email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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