A pragmatic randomized controlled trial comparing selective adrenal artery embolization and spironolactone on target organ damage and disease outcomes in patients with idiopathic aldosteronism

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050884

Enrollment

Unknown

Registered

2021-09-06

Start date

2018-01-01

Completion date

Unknown

Last updated

2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary aldosteronism

Interventions

Super selective adrenal artery embolization(SAAE) group:Super selective adrenal artery embolization

Spironolactone Treatment Group:Spironolactone therapy

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years, males and females; 2. At least 3 non ambulatory office BP >= 140 / 90 mmHg while not taking antihypertensive medication or if either the 24-h ambulatory BP average throughout the day is > 130/80 mmHg or the daytime average BP is > 135/85 mmHg; 3. Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution; 4. The diagnosis of idiopathic hyperaldosteronism was confirmed by Adrenal Venous Sampling; 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 super selective adrenal artery embolizatio.

Exclusion criteria

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. Patients with other serious organic diseases can not tolerate the treatment of super selective adrenal artery embolizatio; 5. A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent; 6. The diameter of adrenal space occupying lesions was more than 2 cm; 7. History of severe contrast allergy; 8. The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.

Design outcomes

Primary

Measure	Time frame
left ventricular mass index;urinary microalbumin / creatinine ratio;estimated glomerular filtration rate;adverse events;home blood pressure;ambulatory blood pressure monitoring;plasma aldosterone concentration;plasma renin activity;blood potassium concentration;Plain or enhanced CT scan of adrenal gland;Type of antihypertensive drugs;	—

Countries

China

Contacts

Public ContactYi-Fei Dong

The Second Affiliated Hospital of Nanchang University

yf_dong66@126.com+86 13576007061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026