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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05501080
Other study ID # IIT-2022-073
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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