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RecruitingNCT05501080Updated May 16, 2025

The Effect of SAAE on Ventricular Remodeling in PA Patients

An interventional study of Super selective adrenal artery embolization and Spironolactone in Primary Aldosteronism, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Aldosteronism

Keywords

  • primary aldosteronism
  • selective adrenal artery embolization
  • bilateral primary aldosteronism
  • Nondominant Lateral Secretory Primary Aldosteronism
  • Ventricular Remodeling
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 112 is above the median of 63 across 94 interventional 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 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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) 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 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 approved by the ethics committee before the screening.

Exclusion criteria

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(\<45 mL/min/1.73 m2);
  • (4) Severe allergy to contrast medium;
  • (5) Other serious organic diseases, \< 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.
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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    SAAE group

    Subjects received super selective adrenal artery embolization treatment

    Other: Super selective adrenal artery embolization

  • Active comparator
    Spironolactone group

    Subjects received spironolactone treatment

    Drug: Spironolactone

Interventions

  • OtherSuper 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.

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

06

What researchers measure

Primary outcomes

  1. LVMI

    Left ventricular mass index(LVMI)

    Time frame: 12 months after SAAE

Secondary outcomes

  1. LVH

    left ventricular hypertrophy

    Time frame: 12 months after SAAE

  2. ABPM

    24-hour ambulatory blood pressure monitor

    Time frame: 1 month after SAAE

  3. ABPM

    24-hour ambulatory blood pressure monitor

    Time frame: 12 months after SAAE

  4. PAC

    plasma aldosterone concentration

    Time frame: 1 month after SAAE

  5. PAC

    plasma aldosterone concentration

    Time frame: 12 months after SAAE

  6. PRA

    plasma renin activity

    Time frame: 1 month after SAAE

  7. PRA

    plasma renin activity

    Time frame: 12 months after SAAE

  8. ARR

    aldosterone-to-renin ratio

    Time frame: 1 month after SAAE

  9. ARR

    aldosterone-to-renin ratio

    Time frame: 12 months after SAAE

  10. Serum potassium

    Serum potassium

    Time frame: 1 month after SAAE

  11. Serum potassium

    Serum potassium

    Time frame: 12 months after SAAE

  12. serum creatinine

    serum creatinine

    Time frame: 1 month after SAAE

  13. serum creatinine

    serum creatinine

    Time frame: 12 months after SAAE

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05501080
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Yifei Dong (Professor, Second Affiliated Hospital of Nanchang University) — Principal investigator
First posted
Aug 15, 2022
Start date
Sep 1, 2022
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 16, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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