The Effect of SAAE on Ventricular Remodeling in PA Patients

Not Applicable

Recruiting

• Conditions: Primary Aldosteronism
• Interventions: Drug: Spironolactone; Other: Super selective adrenal artery embolization

• Registration Number: NCT05501080
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-12
• Study First Posted: 2022-08-15
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spironolactone group	Spironolactone	Subjects received spironolactone treatment
SAAE group	Super selective adrenal artery embolization	Subjects received super selective adrenal artery embolization treatment

Primary Outcome Measures

Name	Time	Method
LVMI	12 months after SAAE	Left ventricular mass index(LVMI)

Secondary Outcome Measures

Name	Time	Method
ABPM	12 months after SAAE	24-hour ambulatory blood pressure monitor
PRA	12 months after SAAE	plasma renin activity
serum creatinine	12 months after SAAE	serum creatinine
ARR	12 months after SAAE	aldosterone-to-renin ratio
Serum potassium	12 months after SAAE	Serum potassium
LVH	12 months after SAAE	left ventricular hypertrophy
PAC	12 months after SAAE	plasma aldosterone concentration

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China