An interventional study of Endovascular chemical Ablation of Adrenal Gland in Primary Aldosteronism and Hypertension, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment
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.
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This study's planned enrollment of 60 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol.
Procedure: Endovascular chemical Ablation of Adrenal Gland
Patients in this group will be treated with aldosterone 20-80mg daily according to blood pressure
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol
Change of office systolic and diastolic pressure compared with the baseline between two groups
Change of office systolic and diastolic pressure compared with the baseline between the intervention and control group at the end of the study
Time frame: 3 years(End of Trial)
Incidence of major adverse cardiac events (MACE)(%) between two groups
Incidence of major adverse cardiac events (MACE)(%)（cardiac death, myocardial infarction and target vessel revascularisation） between two groups at the end of the study
Time frame: 3 years(End of Trial)
Change of 24-h average systolic blood pressure between two groups
Change of 24-h average systolic blood pressure between two groups at end of the study
Time frame: 3 years(End of Trial)
Change of 24-h average diastolic blood pressure between two groups
Change of 24-h average diastolic blood pressure between two groups at end of the study
Time frame: 3 years(End of Trial)
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups at end of the study
Time frame: 3 years(End of Trial)
Change of carotid intima-media thickness assessed by carotid ultrasound between two groups
Change of carotid intima-media thickness assessed by carotid ultrasound between two groups at end of the study
Time frame: 3 years(End of Trial)
Plan to share: No
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Third Military Medical University