A Phase 3 interventional study of Endovascular chemical Ablation of Adrenal Gland in Primary Aldosteronism and Hypertension, sponsored by Third Military Medical University. Completed at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Third Military Medical University · Phase 3, 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.
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.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's enrollment of 66 is close to the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adrenal Artery Ablation
Procedure: Endovascular chemical Ablation of Adrenal Gland
No intervention, but treated with standard anti-hypertensive drigs
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
Change of 24-h average systolic blood pressure 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 24-h average systolic blood pressure between two groups
Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of anti-hypertensive regimen between two groups
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)
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 between two groups
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)
Time frame: 24 weeks
Change of office systolic and diastolic pressure between two groups
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
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)
Time frame: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone
Change of plasma aldosterone and 24-h urine aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
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)
Time frame: 24 weeks
Change of plasma cortisol and 24-h urine cortisol
Change of plasma cortisol and 24-h urine cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of liver enzymes (ALT, AST)
Change of liver enzymes (ALT, AST) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
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)
Time frame: 24 weeks
Change of fasting blood glucose
Change of fasting blood glucose in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of testosterone and estrogen levels
Change of testosterone and estrogen levels compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
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)
Time frame: 24 weeks
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM)
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of carotid intima-media thickness assessed by carotid ultrasound
Change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Change of electrocardiogram manifestations
Change of electrocardiogram manifestations(heart rhythms, heart rates and arrhythmia ) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time frame: 24 weeks
Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Third Military Medical University