The Effect of SAAE on Ventricular Remodeling in PA Patients

Second Affiliated Hospital of Nanchang University112 enrolled

Overview

The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.

After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Primary Aldosteronism

Interventions

Super selective adrenal artery embolizationOTHER

Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.

SpironolactoneDRUG

Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING