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NCT Number: NCT06228677

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

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.

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Key information

Conditions

Resistant Hypertension Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism Primary Aldosteronism Secondary Hypertension Secondary Hypertension to Endocrine Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

Location status: Recruiting

Location contact

Peijian Wang, PhD

CONTACT

[email protected]

028-83016145 ext. +86

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Selective adrenal artery embolization

Procedure

Percutaneous selective adrenal artery embolization in patients with primary aldosteronism

Primary outcomes

  1. Invasive blood pressure

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Auxiliary check

  2. 24-hour dynamic blood pressure

    Time frame: Selective adrenal artery embolization before 24 hours, after 24 hours

    Auxiliary check

  3. Plasma Norepinephrine

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  4. Plasma Adrenaline

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  5. Plasma Dopamin

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  6. Plasma Renin

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  7. Plasma Aldosterone

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  8. Serum sodium

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

  9. Serum potassium

    Time frame: Selective adrenal artery embolization immediately, after 5 minutes, 15 minutes, 30 minutes

    Biochemical indicators

Study contacts

Contact information is provided by the study sponsor or research team.

Peijian Wang, PhD

CONTACT

[email protected]

028-83016145 ext. +86

Sen Liu, MD

CONTACT

[email protected]

028-83016150 ext. +86

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chengdu Medical College

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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