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RecruitingNCT05561361Updated Dec 15, 2025

The Effect of SAAE on Vascular Endothelial Function in PA Patients

An observational study in Primary Aldosteronism, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Second Affiliated Hospital of Nanchang University · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed description

After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.

02

Conditions studied

  • Primary Aldosteronism

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Keywords

  • primary aldosteronism
  • selective adrenal artery embolization
  • vascular endothelial function
03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 103 observational studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 85 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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) 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.

Exclusion criteria

Exclusion Criteria:

  • (1)Secondary hypertension of other causes;
  • (2)Pregnant women or those who have a fertility plan in the next year;
  • (3) EGFR \< 45 ml/min/1.73m\^2;
  • (4)History of severe contrast allergy;
  • (5)Hyperkalemia;
  • (6)Patients with other serious organic diseases or \< 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 ;
  • (9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureSuper 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.

    Also known as: SAAE

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

06

What researchers measure

Primary outcomes

  1. endothelial function

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

    Time frame: 1 month after SAAE

  2. endothelial function

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

    Time frame: 12 months after SAAE

Secondary outcomes

  1. PAC

    plasma aldosterone concentration

    Time frame: 1 month after SAAE

  2. PAC

    plasma aldosterone concentration

    Time frame: 12 months after SAAE

  3. PRA

    plasma renin activity

    Time frame: 1 month after SAAE

  4. PRA

    plasma renin activity

    Time frame: 12 months after SAAE

  5. ARR

    aldosterone-to-renin ratio

    Time frame: 1 month after SAAE

  6. ARR

    aldosterone-to-renin ratio

    Time frame: 12 months after SAAE

  7. Serum potassium

    Serum potassium

    Time frame: 1 month after SAAE

  8. Serum potassium

    Serum potassium

    Time frame: 12 months after SAAE

  9. serum creatinine

    serum creatinine

    Time frame: 1 month after SAAE

  10. serum creatinine

    serum creatinine

    Time frame: 12 months after SAAE

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05561361
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Oct 1, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 15, 2025

Study contacts

Yifei Dong, Doctorate
Contact
yf_dong66@126.com
+8613576007061
Yifei Dong
study director · Second Affiliated Hospital of Nanchang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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