Comparing catecholamine levels in blood during adrenal artery embolization for hypertension

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

This study is trying to see how blood pressure changes during a specific treatment for high blood pressure in people with primary aldosteronism and how it relates to certain hormones in the blood.

Quick facts

• Study type: Observational
• Enrollment: 196 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Chengdu Medical College (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06228677 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between blood pressure fluctuations and catecholamine concentrations in patients with primary aldosteronism undergoing selective adrenal artery embolization (SAAE). The study aims to collect adrenal and peripheral venous blood samples during the procedure to analyze catecholamine levels and understand the mechanisms behind blood pressure changes. By identifying patterns in these fluctuations, the research seeks to provide insights that could improve the safety and efficacy of SAAE as a treatment for resistant hypertension. The findings may help clarify why some patients experience significant blood pressure increases during the procedure while others do not.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with primary aldosteronism and experiencing resistant hypertension.

Not a fit: Patients with primary hypertension or secondary hypertension from other causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of blood pressure management during SAAE, leading to improved outcomes for patients with primary aldosteronism.

How similar studies have performed: While the approach of analyzing catecholamine levels during SAAE is relatively novel, similar studies have shown that understanding hormonal fluctuations can lead to better management of hypertension.

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.

Where this trial is running

Chengdu, Sichuan

• The First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Peijian Wang, PhD — First Affiliated Hospital of Chengdu Medical College
• Study coordinator: Peijian Wang, PhD

Conditions Resistant Hypertension; Secondary Hypertension; Secondary Hypertension to Endocrine Disorders; Primary Aldosteronism; Selective Adrenal Artery Embolization; catecholamine concentration; Adrenal Venous Blood; Blood Pressure Variability