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

F

First Affiliated Hospital of Chengdu Medical College

Status

Enrolling

Conditions

Resistant Hypertension
Primary Aldosteronism
Secondary Hypertension
Secondary Hypertension to Endocrine Disorders

Treatments

Procedure: Selective adrenal artery embolization

Study type

Observational

Funder types

Other

Identifiers

NCT06228677
CCC-SAAE

Details and patient eligibility

About

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.

Full 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.

Enrollment

196 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

196 participants in 2 patient groups

Adrenal Venous Sampling Group
Description:
Adrenal veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Treatment:
Procedure: Selective adrenal artery embolization
Peripheral Venous Sampling Group
Description:
Peripheral veinous sampling in patients with primary aldosteronism who underwent percutaneous selective adrenal artery embolization
Treatment:
Procedure: Selective adrenal artery embolization

Trial contacts and locations

1

Loading...

Central trial contact

Peijian Wang, PhD; Sen Liu, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems