Evaluating the impact of adrenal artery embolization on heart changes in patients with primary aldosteronism
Official title: The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism: A Randomized Controlled Clinical Study
Run by Second Affiliated Hospital of Nanchang University · NCT05501080 · Data updated 2026-11-12
This study is testing whether a procedure called adrenal artery embolization can improve heart changes in people with primary aldosteronism compared to taking a medication called spironolactone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang) |
| Status | Recruiting |
| Started | September 1, 2022 |
| Main results expected | September 1, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | May 16, 2025 |
| Trial ID | NCT05501080 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-60 with confirmed bilateral primary aldosteronism and specific blood pressure criteria.
✕Probably not a fit
Patients with primary hypertension or secondary hypertension from other causes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of superselective adrenal artery embolization on ventricular remodeling in patients diagnosed with primary aldosteronism, specifically those without lateralized aldosterone secretion. Participants will undergo a 2-week screening to determine eligibility and will then be randomized into two groups: one receiving the embolization procedure and the other receiving spironolactone therapy. The aim is to compare the outcomes of these two treatment approaches in managing the condition.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may improve heart health in patients with primary aldosteronism.
How similar studies have gone: While similar approaches have been explored, this specific intervention in the context of primary aldosteronism is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Age 18-60 years old, regardless of gender; * (2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure \> 130/80 mmHg or daytime blood pressure \> 135/85 mmHg; * (3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling; * (4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization; * (5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening. Exclusion Criteria: * (1) Primary hypertension or secondary hypertension with other causes; * (2) A woman who is pregnant or lactating, or has a birth plan for the next year; * (3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR\<45 mL/min/1.73 m2); * (4) Severe allergy to contrast medium; * (5) Other serious organic diseases, life expectancy \< 12 months; * (6) Adrenal CT showed adenoma.; * (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
Where it's running
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The Second Affiliated Hospital of Nanchang University
Nanchang, China Recruiting
Study contacts
- Study coordinator: Yifei Dong, Doctorate
- Email: yf_dong66@126.com
- Phone: +8613576007061
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Inclisiran vs. Statin for Primary Aldosteronism
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Metomidate PET-CT vs Usual Care for Primary Aldosteronism
This study tests whether [11C] metomidate PET-CT can help orient treatment for people with primary aldosteronism compared with the usual adrenal venous sampling approach.
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Captopril Test with LC-MS/MS for Aldosterone and Renin in Primary Aldosteronism
This study tests whether measuring aldosterone with LC-MS/MS during a captopril test can better diagnose primary aldosteronism.
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Finerenone vs. Spironolactone for Primary Aldosteronism
This trial tests whether finerenone works as well as spironolactone to lower blood pressure and improve related health measures in adults with primary aldosteronism.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.