Clinical trial NCT03660397: Adrenal Artery Ablation for Uncontrolled Hypertension
Official title: Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Uncontrolled Hypertension: A Randomized, Parallel, Active-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uncontrolled Hypertension
Keywords: Uncontrolled Hypertension
Resistant hypertension
Aldosterone
Ablation
Adrenal Gland
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.

With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged between 30-60 years old.
* Patients with poorly controlled hypertension (office blood pressure ≥130/80 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks
* Positional blood aldosterone ≥100pg/ml.
* Informed consent signed and agreed to participate in this trial.

Exclusion Criteria:

* Hyperkalemia or hypokalemia.
* Secondary hypertension.
* History of depression, schizophrenia or vascular dementia.
* Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
* Adrenergic insufficiency.
* Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
* Acute infections, tumors and severe arrhythmias, psychiatric disorders,
* drugs or alcohol addicts.
* Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
* Fertile woman without contraceptives.
* Coagulation dysfunction.
* Pregnant women or lactating women.
* Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
* Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
* Allergy or any contraindications for the study drugs, contrast agents and alcohol.
* Refused to sign informed consent

Primary outcomes:
measure: Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of 24-h average systolic blood pressure compared with the baseline
timeFrame: 24 weeks
measure: Change of anti-hypertensive regimen measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: Change of home systolic and diastolic pressure measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of office systolic and diastolic pressure measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of blood electrolytes measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of plasma and urine adrenal hormones measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of plasma renin measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of liver enzymes measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of kidney function measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of fasting blood glucose measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of lipids profiles measured at baseline and the end of the trial
timeFrame: 24 weeks
Other outcomes:
measure: Change of sex hormones measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of 24-h urine microalbumin measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of echocardiography measured at baseline and the end of the trial
timeFrame: 24 weeks
measure: Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
timeFrame: 24 weeks
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References: