The Effect of SAAE on Ventricular Remodeling in PA Patients

Sponsor

Second Affiliated Hospital of Nanchang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05501080

Collaborator

(none)

112

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Other: Super selective adrenal artery embolization Drug: Spironolactone	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

LVMI [12 months after SAAE]
Left ventricular mass index(LVMI)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.