NCT05561361

Brief Summary

The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Oct 2022

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

September 27, 2022

Last Update Submit

December 7, 2025

Conditions

Primary Aldosteronism

Keywords

primary aldosteronismselective adrenal artery embolizationvascular endothelial function

Outcome Measures

Primary Outcomes (2)

  • endothelial function

    Brachial artery endothelial function measured by flow-mediated dilation(FMD)

    1 month after SAAE

  • endothelial function

    Brachial artery endothelial function measured by flow-mediated dilation(FMD)

    12 months after SAAE

Secondary Outcomes (10)

  • PAC

    1 month after SAAE

  • PAC

    12 months after SAAE

  • PRA

    1 month after SAAE

  • PRA

    12 months after SAAE

  • ARR

    1 month after SAAE

  • +5 more secondary outcomes

Study Arms (2)

SAAE group

Subjects received super selective adrenal artery embolization treatment

Procedure: Super selective adrenal artery embolization

Spironolactone group

Subjects received spironolactone treatment

Drug: Spironolactone

Interventions

SpironolactoneDRUG

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

Spironolactone group
Super selective adrenal artery embolizationPROCEDURE

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.

Also known as: SAAE
SAAE group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.

You may qualify if:

  • (1)Aged 18-75 years, males and females;
  • (2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging \>130/80 mmHg throughout the day or averaging \>135/85 mmHg during the day;
  • (3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
  • (4)Contraindications to spironolactone-free administration;
  • (5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
  • (6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.

You may not qualify if:

  • (1)Secondary hypertension of other causes;
  • (2)Pregnant women or those who have a fertility plan in the next year;
  • (3)Glomerular filtration rate EGFR \< 45 ml/min/1.73m\^2;
  • (4)History of severe contrast allergy;
  • (5)Hyperkalemia;
  • (6)Patients with other serious organic diseases or life expectancy \< 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;
  • (7)The diameter of adrenal space occupying lesions was more than 2 cm;
  • (8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;
  • (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.

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

Hyperaldosteronism

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yifei Dong

    Second Affiliated Hospital of Nanchang University

    STUDY DIRECTOR

Central Study Contacts

Yifei Dong, Doctorate

CONTACT

+8613576007061yf_dong66@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 15, 2025

Record last verified: 2025-05

Locations

CN(1)