NCT05501080

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

August 12, 2022

Last Update Submit

May 13, 2025

Conditions

Primary Aldosteronism

Keywords

primary aldosteronismselective adrenal artery embolizationbilateral primary aldosteronismNondominant Lateral Secretory Primary AldosteronismVentricular Remodeling

Outcome Measures

Primary Outcomes (1)

  • LVMI

    Left ventricular mass index(LVMI)

    12 months after SAAE

Secondary Outcomes (13)

  • LVH

    12 months after SAAE

  • ABPM

    1 month after SAAE

  • ABPM

    12 months after SAAE

  • PAC

    1 month after SAAE

  • PAC

    12 months after SAAE

  • +8 more secondary outcomes

Study Arms (2)

SAAE group

EXPERIMENTAL

Subjects received super selective adrenal artery embolization treatment

Other: Super selective adrenal artery embolization

Spironolactone group

ACTIVE COMPARATOR

Subjects received spironolactone treatment

Drug: Spironolactone

Interventions

Super selective adrenal artery embolizationOTHER

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.

SAAE group
SpironolactoneDRUG

Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.

Spironolactone group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

MeSH Terms

Conditions

HyperaldosteronismVentricular Remodeling

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yifei Dong, Doctorate

    Second Affiliated Hospital of Nanchang University

    STUDY DIRECTOR

Central Study Contacts

Yifei Dong, Doctorate

CONTACT

+8613576007061yf_dong66@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)