Treatment for Primary Aldosteronism using Ablation and Spironolactone

An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism

This study is testing a new treatment that combines a procedure to target the adrenal gland with spironolactone to see if it can help people with primary aldosteronism manage their high blood pressure better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 30 Years to 60 Years
• Sex: All
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT04409431 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of endovascular chemical ablation of the adrenal gland combined with spironolactone in patients diagnosed with primary aldosteronism. Primary aldosteronism is a significant cause of resistant hypertension, and current treatment options are limited, particularly for patients with bilateral adrenal hyperplasia. The study aims to evaluate the efficacy of this combined approach in managing hypertension and reducing the adverse effects associated with long-term spironolactone use. Participants will be closely monitored for changes in blood pressure and potential side effects.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with primary aldosteronism who have not undergone surgical excision and meet specific inclusion criteria.

Not a fit: Patients with aldosterone cancer, hyperkalemia, or secondary hypertension will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and safer management option for patients with primary aldosteronism.

How similar studies have performed: While there is limited data on this specific combined approach, similar interventions have shown promise in managing primary aldosteronism.

Eligibility criteria

Inclusion Criteria:

* Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
* Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
* The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
* Signed informed consent and agreed to participate in this study.

Exclusion Criteria:

* Aldosterone cancer.
* Hyperkalemia.
* Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
* Secondary hypertension except the primary aldosteronism.
* Adrenergic insufficiency.
* Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
* Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts.
* Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
* Coagulation dysfunction.
* Pregnant women or lactating women.
* Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
* Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
* Allergy or any contraindications for the study drugs, contrast agents and alcohol.
* Refused to sign informed consent

Where this trial is running

Chongqing, Chongqing Municipality

• The third hospital affiliated to the Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Li Yingsha, MD

Conditions Primary Aldosteronism; Hypertension; Adrenal Artery Ablation; Spironolactone