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NCT Number: NCT07328230

Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism

Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality, China

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About this study

Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged from 15 to 60 with no limits in sex;
  • Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
  • Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
  • Patients or their legal representatives have to sign written informed consent approved by the ethics committee.

Exclusion criteria

  • Unilateral adrenal hyperplasia;
  • Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) <45 ml/min/1.73 m², and/or serum creatinine >176 μmol/L;
  • Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
  • Severe contrast agent allergy;
  • Women who are pregnant or planning to become pregnant;
  • Patients with other serious organic diseases cannot tolerate SAAE treatment;
  • Other forms of secondary hypertension.

Treatment and study plan

Superselective adrenal arterial embolization

Procedure

Patients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation.

Spironolactone

Drug

Patients will be treated with spironolactone.

Primary outcomes

  1. Change of 24-h mean systolic blood pressure at 6 months compared with baseline.

    Time frame: 6 months after randomization

    change of 24-h mean systolic blood pressure at 6 months compared with baseline.

Secondary outcomes

  1. Change of 24-h mean diastolic blood pressure at 6 months compared with baseline.

    Time frame: 6 months after randomization

    change of 24-h mean diastolic blood pressure at 6 months compared with baseline.

  2. Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline

    Time frame: 1, 3, 6 months after randomization

    Change of office blood pressure at 1, 3, 6 months compared with baseline

  3. change of antihypertensive medication burden at 1, 3, 6 months compared with baseline

    Time frame: 1, 3, 6 months after randomization

    change of antihypertensive medication burden at 6 months compared with baseline

  4. Incidence of clinical events

    Time frame: 6 months after randomization

    Incidence of clinical events including: major adverse cardiovascular events(MACE), renal insufficiency, adrenal insufficiency, hyperkalemia, vascular complication, flank/back pain, gynecomastia, breast tenderness, sexual dysfunction,etc.

  5. Change of Serum potassium at 3, 6 months after randomization, compared with baseline

    Time frame: 3,6 months after randomization

    Change of Serum potassium at 3, 6 months compared with baseline

  6. Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline

    Time frame: 3, 6 months after randomization

    Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline

  7. Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline

    Time frame: 3, 6 months after randomization

    Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Dong, MD

CONTACT

[email protected]

86-010-88322387

Xiongjing Jiang, MD

CONTACT

[email protected]

86-010-88322387

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Collaborators

  • First Affiliated Hospital of Chengdu Medical College
  • Second Affiliated Hospital of Nanchang University

Registry information

Official study title

A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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