The Effect of SAAE on Ventricular Remodeling in PA Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Aldosteronism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAAE group

Subjects received super selective adrenal artery embolization treatment

Group Type EXPERIMENTAL

Super selective adrenal artery embolization

Intervention Type 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 group

Subjects received spironolactone treatment

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type OTHER

Spironolactone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No