The Effect of SAAE on Ventricular Remodeling in PA Patients

Nanchang University

Status: Enrolling

Conditions: Primary Aldosteronism

Treatments: Other: Super selective adrenal artery embolization; Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT05501080

IIT-2022-073

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

SAAE group

Experimental group

Description:

Subjects received super selective adrenal artery embolization treatment

Treatment:

Other: Super selective adrenal artery embolization

Spironolactone group

Active Comparator group

Description:

Subjects received spironolactone treatment

Treatment:

Drug: Spironolactone