Clinical trial NCT05501080: The Effect of SAAE on Ventricular Remodeling in PA Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Aldosteronism
Keywords: primary aldosteronism
selective adrenal artery embolization
bilateral primary aldosteronism
Nondominant Lateral Secretory Primary Aldosteronism
Ventricular Remodeling
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: LVMI
timeFrame: 12 months after SAAE
Secondary outcomes:
measure: LVH
timeFrame: 12 months after SAAE
measure: ABPM
timeFrame: 1 month after SAAE
measure: ABPM
timeFrame: 12 months after SAAE
measure: PAC
timeFrame: 1 month after SAAE
measure: PAC
timeFrame: 12 months after SAAE
measure: PRA
timeFrame: 1 month after SAAE
measure: PRA
timeFrame: 12 months after SAAE
measure: ARR
timeFrame: 1 month after SAAE
measure: ARR
timeFrame: 12 months after SAAE
measure: Serum potassium
timeFrame: 1 month after SAAE
measure: Serum potassium
timeFrame: 12 months after SAAE
measure: serum creatinine
timeFrame: 1 month after SAAE
measure: serum creatinine
timeFrame: 12 months after SAAE
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: Yifei Dong, Doctorate
role: STUDY_DIRECTOR
References: