Primary aldosteronism (PA) is one of the most common causes 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. The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions. Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
Patients will be treated with different antihypertensive drugs in two groups.
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe third hospital affiliated to the Third Military Medical University
Chongqing, China
RECRUITINGChange of 24-h average systolic blood pressure measured at baseline and the end of the trial
Difference in the change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial
Difference in the change of blood electrolytes（serum potassium and natrium in mmol/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone measured at baseline and the end of the trial
Difference in the change of plasma aldosterone and 24-h urine aldosterone compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of plasma renin measured at baseline and the end of the trial
Difference in the change of plasma renin compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of 24-h average systolic blood pressure measured at the end of the trial compared with the baseline
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Time frame: 24 weeks
Change of anti-hypertensive regimen assessed at baseline and the end of the trial
Difference in the change of anti-hypertensive regimen compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
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 measured at baseline and the end of the trial
Difference in the 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of home systolic and diastolic pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of office systolic and diastolic pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of liver enzymes measured at baseline and the end of the trial
Difference in the change of liver enzymes (ALT, AST in IU/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of kidney function measured at baseline and the end of the trial
Difference in the change of serum creatinine in umol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of fasting blood glucose and lipids profiles measured at baseline and the end of the trial
Difference in the change of fasting blood glucose and lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of sex hormones measured at baseline and the end of the trial
Difference in the change of 17-OH, DHEAS, testosterone and estrogen levels compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) measured at baseline and the end of the trial
Difference in the change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre(mm), and LVEF(%), LVM in gram) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
Difference in the change of carotid intima-media thickness(CIMT) in millimetre(mm) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.