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Recruiting NCT05501080

The Effect of SAAE on Ventricular Remodeling in PA Patients

No phase Interventional Primary Aldosteronism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Super selective adrenal artery embolization, Spironolactone.
Who it may be relevant to
Registry conditions: Primary Aldosteronism. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • LVMI [Time frame: 12 months after SAAE]
Secondary outcome measures (12)
  • LVH [Time frame: 12 months after SAAE]
  • ABPM [Time frame: 1 month after SAAE]
  • ABPM [Time frame: 12 months after SAAE]
  • PAC [Time frame: 1 month after SAAE]
  • PAC [Time frame: 12 months after SAAE]
  • PRA [Time frame: 1 month after SAAE]
  • PRA [Time frame: 12 months after SAAE]
  • ARR [Time frame: 1 month after SAAE]
  • ARR [Time frame: 12 months after SAAE]
  • Serum potassium [Time frame: 1 month after SAAE]
  • Serum potassium [Time frame: 12 months after SAAE]
  • serum creatinine [Time frame: 1 month after SAAE]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Nanchang University — Nanchang

Identifiers

NCT: NCT05501080 · IIT-2022-073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗