The Effect of SAAE on Ventricular Remodeling in PA Patients

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501080
• Other study ID #: IIT-2022-073
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Yifei Dong, Doctorate
• Phone: +8613576007061
• Email: yf_dong66[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism
• Ventricular Remodeling

Intervention

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.

Drug:
• Spironolactone
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanchang University	Nanchang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVMI	Left ventricular mass index(LVMI)	12 months after SAAE
Secondary	LVH	left ventricular hypertrophy	12 months after SAAE
Secondary	ABPM	24-hour ambulatory blood pressure monitor	1 month after SAAE
Secondary	ABPM	24-hour ambulatory blood pressure monitor	12 months after SAAE
Secondary	PAC	plasma aldosterone concentration	1 month after SAAE
Secondary	PAC	plasma aldosterone concentration	12 months after SAAE
Secondary	PRA	plasma renin activity	1 month after SAAE
Secondary	PRA	plasma renin activity	12 months after SAAE
Secondary	ARR	aldosterone-to-renin ratio	1 month after SAAE
Secondary	ARR	aldosterone-to-renin ratio	12 months after SAAE
Secondary	Serum potassium	Serum potassium	1 month after SAAE
Secondary	Serum potassium	Serum potassium	12 months after SAAE
Secondary	serum creatinine	serum creatinine	1 month after SAAE
Secondary	serum creatinine	serum creatinine	12 months after SAAE