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NCT Number: NCT05501080

The Effect of SAAE on Ventricular Remodeling in PA Patients

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Super selective adrenal artery embolization

Other

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.

Spironolactone

Drug

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

Primary outcomes

  1. LVMI

    Time frame: 12 months after SAAE

    Left ventricular mass index(LVMI)

Secondary outcomes

  1. LVH

    Time frame: 12 months after SAAE

    left ventricular hypertrophy

  2. ABPM

    Time frame: 1 month after SAAE

    24-hour ambulatory blood pressure monitor

  3. ABPM

    Time frame: 12 months after SAAE

    24-hour ambulatory blood pressure monitor

  4. PAC

    Time frame: 1 month after SAAE

    plasma aldosterone concentration

  5. PAC

    Time frame: 12 months after SAAE

    plasma aldosterone concentration

  6. PRA

    Time frame: 1 month after SAAE

    plasma renin activity

  7. PRA

    Time frame: 12 months after SAAE

    plasma renin activity

  8. ARR

    Time frame: 1 month after SAAE

    aldosterone-to-renin ratio

  9. ARR

    Time frame: 12 months after SAAE

    aldosterone-to-renin ratio

  10. Serum potassium

    Time frame: 1 month after SAAE

    Serum potassium

  11. Serum potassium

    Time frame: 12 months after SAAE

    Serum potassium

  12. serum creatinine

    Time frame: 1 month after SAAE

    serum creatinine

  13. serum creatinine

    Time frame: 12 months after SAAE

    serum creatinine

Study contacts

Contact information is provided by the study sponsor or research team.

Yifei Dong, Doctorate

CONTACT

[email protected]

+8613576007061

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Official study title

The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism: A Randomized Controlled Clinical Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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