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Clinical prospective randomized controlled study of unilateral / bilateral superselective adrenal artery embolism in the treatment of Idiopathic aldosteronism

Clinical prospective randomized controlled study of unilateral / bilateral superselective adrenal artery embolism in the treatment of Idiopathic aldosteronism

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077427
Enrollment
Unknown
Registered
2023-11-08
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Idiopathic hyperaldosteronism

Interventions

Bilateral Intervention Group:Bilateral superselective adrenal artery embolization
Unilateral SAAE:Unilateral superselective adrenal artery embolization

Sponsors

The First Affiliated Hospital of Chengdu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, no gender limits. 2. Preparation. All antihypertensive drugs should be stopped at least 4 weeks. Verapamil (180-240 mg/d), prazosin (6-15 mg/d), and levamlodipine (2.5-5 mg/d) could be added in sequence when office blood pressure exceed 140/90 mmHg. Hypokalemia should be corrected with oral potassium chloride supplementation. Finally, patients with sitting blood pressure less than 160/100mmHg and serum potassium concentration exceeds 3.5mmol/L were screened for primary aldosteronism. 3. Aldosterone/renin activity ratio (ARR) >= 38 (pg/ml). 4. Primary aldosteronism confirmed by saline infusion test captopril test. 5. Bilateral adrenal hyperplasia or no obvious abnormality in CT image. 6. Adrenal vein blood sampling (AVS) is successful.

Exclusion criteria

Exclusion criteria: 1.Severe organic disease. 2. Pregnant and birth-giving women. 3. Myocardial infarction or stroke within 2 months, aortic dissection involving the abdominal aorta. 4. Other secondary hypertension. 5. Solitary mass >10 mm in lateralization of adrenal according to AVS, and aldosterone-producing adenoma cannot be excluded. 6. Serum creatinine =1.5mg/dl. 7. Severe contrast agent allergy. 8.Abnormal adrenal artery anatomy which is not suitable for SAAE.

Design outcomes

Primary

MeasureTime frame
Office blood pressure;Ambulatory blood pressure;

Secondary

MeasureTime frame
Use of antihypertensive drugs;Serum potassium;Serum sodium;Plasma renin;Plasma aldosterone;

Countries

China

Contacts

Public ContactWang Peijian

The First Affiliated Hospital of Chengdu Medical College

wpjmed@aliyun.com+86 189 8071 8263

Outcome results

None listed

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