Evaluating the impact of adrenal artery embolization on heart changes in patients with primary aldosteronism

The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism： A Randomized Controlled Clinical Study

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

• Phase: NA
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Nanchang University (other)
• Locations: 1 site (Nanchang)
• Trial ID: NCT05501080 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with confirmed bilateral primary aldosteronism and specific blood pressure criteria.

Not a fit: Patients with primary hypertension or secondary hypertension from other causes will not benefit from this study.

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 performed: While similar approaches have been explored, this specific intervention in the context of primary aldosteronism is relatively novel.

Eligibility 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 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, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling