Assessing the impact of adrenal artery embolization on blood vessel function in patients with primary aldosteronism

The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation

This study is testing if a procedure called adrenal artery embolization can improve blood vessel function in people with primary aldosteronism compared to taking a medication called spironolactone.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (Academic / other)
• Locations: 1 site (Nanchang)
• Trial ID: NCT05561361 on ClinicalTrials.gov

What this trial studies

This observational study evaluates how superselective adrenal artery embolization affects vascular endothelial function in patients diagnosed with primary aldosteronism. Participants will undergo a two-week screening period to determine eligibility, after which they will be assigned to either the embolization group or the spironolactone therapy group based on their preferences and medical indications. The primary outcome will be measured through brachial artery flow-mediated relaxation, providing insights into the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with diagnosed primary aldosteronism and specific blood pressure criteria.

Not a fit: Patients with secondary hypertension or contraindications to spironolactone will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve vascular health and blood pressure management in patients with primary aldosteronism.

How similar studies have performed: While similar approaches have been explored, this specific intervention's impact on vascular function in primary aldosteronism is novel.

Eligibility criteria

Inclusion Criteria:

* (1)Aged 18-75 years, males and females;
* (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging \>130/80 mmHg throughout the day or averaging \>135/85 mmHg during the day;
* (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
* (4)Contraindications to spironolactone-free administration;
* (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
* (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.

Exclusion Criteria:

* (1)Secondary hypertension of other causes;
* (2)Pregnant women or those who have a fertility plan in the next year;
* (3)Glomerular filtration rate EGFR \< 45 ml/min/1.73m\^2;
* (4)History of severe contrast allergy;
* (5)Hyperkalemia;
* (6)Patients with other serious organic diseases or life expectancy \< 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;
* (7)The diameter of adrenal space occupying lesions was more than 2 cm;
* (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;
* (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.

Where this trial is running

Nanchang

• The Second Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)

Study contacts

• Study coordinator: Yifei Dong, Doctorate

Conditions Primary Aldosteronism; primary aldosteronism; selective adrenal artery embolization; vascular endothelial function