Superselective Adrenal Arterial Embolization for Bilateral Idiopathic Hyperaldosteronism: A Prospective Cohort Study

Phase

N/A

Condition

Congenital Adrenal Hyperplasia

Treatment

N/A

Clinical Study ID

NCT05186675

2021NDEFY21

Ages 18-60
All Genders

Study Summary

The most common two subtypes of primary aldosteronism (PA ) are aldosterone producing adenoma (APA) and bilateral idiopathic hyperaldosteronism (IHA). Mineralocorticoid receptor (MR) antagonists is the main treatment for bilateral IHA, because of its side effects, the treatment compliance of those patients is poor. Hence, an alternative therapy is needed in such cases. We hypothesized that superselective adrenal artery embolization (SAAE) could be a suitable alternative approach. To our knowledge, SAAE has so far not been applied to treat bilateral IHA. This study aimed to evaluate the efficacy and safety of SAAE in the treatment of PA patients with bilateral IHA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(1) Age 18-60 years old, regardless of gender; (2) After strict drug elution, it metthe diagnostic criteria of primary aldosteronism, and bilateral idiopathicaldosteronism was confirmed by adrenal venous sampling; (3) Blood pressure conditionsmeet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory bloodpressure monitoring：whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (4) Adrenal CT showed adrenal hyperplasia, nodules or no obviousmorphological abnormalities； (5) The course of hypertension is more than 6 months； (6)The patient or his legal representative shall sign the written informed consentapproved by the ethics committee before screening.

Exclusion

Exclusion Criteria:

(1) Primary hypertension or secondary hypertension with other causes; (2) A woman whois pregnant or lactating, or has a birth plan in the next year; (3) There are seriousorganic diseases, especially liver and kidney dysfunction; (4) Severe allergy tocontrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6)Adrenal CT showed adenoma. (7) Patients are enrolled or want to participate in otherclinical studies. During the enrollment study, the results of this study will beaffected.

Study Design

January 01, 2022

December 31, 2022

Study Description

Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for more than 5% of the general hypertensive cases and 17-20% of resistant hypertension.The most common PA subtype is bilateral idiopathic hyperaldosteronism (IHA), and medical therapy with mineralocorticoid receptor antagonists (MRAs) is recommended for these patients.The clinical studies showed that PA patients had more cardiovascular events than patients with essential hypertension independent of blood pressure, and PA patients with higher plasma aldosterone levels had a higher cardiovascular risk. However, MRAs are unable to reduce the level of plasma aldosterone. Moreover, the undesirable adverse effects of MRAs also limit their wide application, particularly in men.

Superselective adrenal artery embolization (SAAE) has been used as a minimally invasive alternative for the treatment of adrenal tumors. The clinical efficacy of SAAE has been proved by a number of clinical studies. Since the efficacy and safety of SAAE was justified by the treatment of adrenal tumors and APA, we hypothesized that SAAE might cause a significant reduction of blood pressure in cases of hypertension caused by bilateral IHA. Here, we intend to conduct a prospective cohort study to demonstrate the efficacy and safety of SAAE for bilateral IHA with a one-month follow-up.

Connect with a study center

the Second Affiliated Hospital of Nanchang University
Nanchang, Jiagxi 330006
China
Site Not Available

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