The Effect of SAAE on Ventricular Remodeling in PA Patients

The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism： A Randomized Controlled Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: Spironolactone; Other: Super selective adrenal artery embolization

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 Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifei Dong, doctorate; Phone Number: +8613576007061; Email: yf_dong66@126.com

Study Locations

• China
  • Nanchang, China
    • Recruiting
    • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAAE group; Subjects received super selective adrenal artery embolization treatment	Other: Super selective adrenal artery embolization; 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.
Active Comparator: Spironolactone group; Subjects received spironolactone treatment	Drug: Spironolactone; Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LVMI	Left ventricular mass index(LVMI)	12 months after SAAE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAC	plasma aldosterone concentration	1 month after SAAE
PAC	plasma aldosterone concentration	12 months after SAAE
PRA	plasma renin activity	1 month after SAAE
PRA	plasma renin activity	12 months after SAAE
ARR	aldosterone-to-renin ratio	1 month after SAAE
ARR	aldosterone-to-renin ratio	12 months after SAAE
Serum potassium	Serum potassium	1 month after SAAE
Serum potassium	Serum potassium	12 months after SAAE
serum creatinine	serum creatinine	1 month after SAAE
serum creatinine	serum creatinine	12 months after SAAE
LVH	left ventricular hypertrophy	12 months after SAAE
ABPM	24-hour ambulatory blood pressure monitor	1 month after SAAE
ABPM	24-hour ambulatory blood pressure monitor	12 months after SAAE

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Investigators: Study Director: Yifei Dong, Doctorate, Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: primary aldosteronism; Ventricular Remodeling; selective adrenal artery embolization; bilateral primary aldosteronism; Nondominant Lateral Secretory Primary Aldosteronism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathological Conditions, Anatomical; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Ventricular Remodeling; Hyperaldosteronism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Diuretics; Natriuretic Agents; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Spironolactone
• Other Study ID Numbers: IIT-2022-073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No