Health TrialsbyHealthPanel

The Effect of SAAE on Ventricular Remodeling in PA Patients

ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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;

Disqualifiers

(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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Super selective adrenal artery embolization

    Other intervention

    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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: SAAE groupExperimental treatment 1 intervention
Group B: Spironolactone groupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Nanchang University

Lead sponsor

Source ClinicalTrials.gov
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