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Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance as patients with PA are more susceptible to cardiovascular and cerebrovascular morbidity and mortality than blood-pressure-matched hypertensive patients.
Current guidelines indicate that mineralocorticoid receptor (MR) antagonists and laparoscopic adrenalectomy are the principal treatments for PA.Laparoscopic adrenalectomy is recommended for patients with aldosteronoma or unilateral adrenal hyperplasia. During the past two decades, catheter-based arterial embolization or computed tomography (CT)-guided radiofrequency thermogenesis have been used for aldosteronomas treatment. Although these procedures are claimed to be effective for treatment of aldosteronomas, the evidence comes mostly from case reports or small series. In addition, some PA patients refuse surgery and are intolerant of the adverse effects of MR antagonists; others have persistence of PA after adrenelectomy, but respond poorly to MR antagonists. An alternative therapy is needed in such cases.
In recent years, adrenal artery ablation has also been used to treat primary aldosteronism, which can reduce the level of aldosterone and blood pressure, but its efficacy and safety are not clear. To confirm the effect of adrenal artery ablation on blood pressure, RAAS system and blood potassium, the researchers conducted a parallel control clinical study of patients with primary aldosteronism (Aldosteronoma).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenal Artery Ablation | Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol |
| |
| Adrenalectomy | Patients in this group will be treated with unilateral laparoscopic adrenalectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular chemical ablation of adrenal gland | Procedure | Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of office systolic and diastolic pressure | Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of 24-h average systolic blood pressure | Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of 24-h average diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third hospital affiliated to the Army Medical University | Chongqing | Chongqing Municipality | 400042 | China |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
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Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure between the intervention and control group at the end of the study (24 weeks)
| 52 weeks (End of Trial) |
| Change of home systolic and diastolic pressure | Change of home systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of anti-hypertensive regimen | Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of blood electrolytes(serum potassium and natrium in mmol/L) | Change of blood electrolytes(serum potassium and natrium in mmol/L)compared with baseline, and between the intervention and control group at the end of the study (24 weeks)between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of aldosterone-to-renin ratio (ARR) | Change of aldosterone-to-renin ratio (ARR)compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of plasma aldosterone | Change of plasma aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of plasma renin | Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of plasma cortisol | Change of plasma cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of serum creatinine | Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of estimated glomerular filtration rate(eGFR) | Change of estimated glomerular filtration rate(eGFR) compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| Change of 24-h urine microalbumin, microalbumin/creatinine ratio | Change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with baseline, and between the intervention and control group at the end of the study (24 weeks) | 52 weeks (End of Trial) |
| D002318 | Cardiovascular Diseases |