The Effect of SAAE on Vascular Endothelial Function in PA Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Nanchang University

About this trial

The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1)Aged 18-75 years, males and females;

(2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day;

(3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;

(4)Contraindications to spironolactone-free administration;

Disqualifiers

(1)Secondary hypertension of other causes;

(2)Pregnant women or those who have a fertility plan in the next year;

(3)Glomerular filtration rate EGFR < 45 ml/min/1.73m²;

(4)History of severe contrast allergy;

Trial population

Patients who were diagnosed with primary aldosteronism and underwent adrenal vein sampling at the Second Affiliated Hospital of Nanchang University.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Super selective adrenal artery embolization

    Procedure/Surgery

    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

200 Participants
are divided into 2 treatment groups
Group A: SAAE group1 intervention
Group B: Spironolactone group1 intervention

Trial outcomes

Primary outcomes

1

endothelial function

Brachial artery endothelial function measured by flow-mediated dilation(FMD)

Time frame
1 month after SAAE
2

endothelial function

Brachial artery endothelial function measured by flow-mediated dilation(FMD)

Time frame
12 months after SAAE

Secondary outcomes

1

PAC

plasma aldosterone concentration

Time frame
1 month after SAAE
2

PAC

plasma aldosterone concentration

Time frame
12 months after SAAE
3

PRA

plasma renin activity

Time frame
1 month after SAAE
4

PRA

plasma renin activity

Time frame
12 months after SAAE

Other outcomes

Sponsors and contacts

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