RecruitingNot ApplicableNCT04409431

Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism

An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism


Sponsor

Third Military Medical University

Enrollment

60 participants

Start Date

Dec 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages. Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically. More than 60% of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors. At present, spironolactone is the most commonly used aldosterone receptor inhibitor. Long term use of spironolactone may cause hyperkalemia, hyperplasia of male mammary gland, hairiness of female and other adverse reactions. Therefore, the researchers suggest that partial removal of adrenals can reduce aldosterone level, lower blood pressure and restore potassium metabolism balance. In patients with primary hyperaldosteronism, the level of aldosterone increases, which can cause vascular endothelial dysfunction, myocardial injury and ventricular fibrosis. The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure. Adrenal artery ablation can reduce aldosterone level, but the long-term effect on cardiovascular system is unknown. In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system, the researchers conducted an open cohort study on patients with primary aldosteronism (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). To observe the effect of adrenal artery ablation and spironolactone on blood pressure, blood electrolyte, metabolic index, cardiovascular events and cardiovascular death risk in patients with primary aldosteronism, and to explore its efficacy and safety.


Eligibility

Min Age: 30 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for a condition called primary aldosteronism — where overactive adrenal glands produce too much of a hormone (aldosterone) that raises blood pressure. The treatments being compared are a minimally invasive procedure to reduce adrenal gland activity (adrenal artery ablation) versus a standard blood pressure medication (spironolactone). **You may be eligible if...** - You have been diagnosed with primary aldosteronism confirmed by blood tests - You have a type that affects both adrenal glands (bilateral) or you have a tumor but do not want surgery - You have signed informed consent **You may NOT be eligible if...** - You have adrenal gland cancer - You have high potassium levels (hyperkalemia) - You have kidney failure or significant kidney disease - You have severe heart failure, recent heart attack, or stroke - You are pregnant or breastfeeding - You have significant liver disease or clotting problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndovascular chemical Ablation of Adrenal Gland

Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol


Locations(1)

The third hospital affiliated to the Army Medical University

Chongqing, Chongqing Municipality, China

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NCT04409431


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