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

Last updated: January 19, 2024
Sponsor: First Affiliated Hospital of Chengdu Medical College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Diabetes And Hypertension

Williams Syndrome

Treatment

Selective adrenal artery embolization

Clinical Study ID

NCT06228677
CCC-SAAE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years with no gender restrictions.
  2. Adherence to the "Primary Aldosteronism" Diagnosis and Treatment Guidelines, confirmeddiagnosis of primary aldosteronism following rigorous drug washout, and identificationas 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 pressuremonitoring 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 significantmorphological deviations.
  5. Hypertension history surpassing a duration of 6 months.
  6. Prior to screening, patients or their lawful guardians must provide a signed informedconsent, sanctioned by the ethics committee.

Exclusion

Exclusion Criteria:

  1. Patients diagnosed with primary hypertension or secondary hypertension attributed toother etiologies.
  2. Female participants who are presently pregnant, lactating, or with intentions toconceive within the forthcoming year.
  3. Presence of significant systemic diseases, with particular attention to hepatic andrenal 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 otherclinical trials, the outcomes of which could potentially influence the results of thecurrent study.
  7. The researcher's discretion deems the subject inappropriate for inclusion in the studyfor any given reason.

Study Design

Total Participants: 196
Treatment Group(s): 1
Primary Treatment: Selective adrenal artery embolization
Phase:
Study Start date:
September 18, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan 610500
    China

    Active - Recruiting

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