Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Third Military Medical University36 enrolled

Overview

Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them 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 cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized. With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Resistant Hypertension

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, age between 30-65 years old. * Primary aldosteronism with resistant hypertension. * Informed consent signed and agreed to participate in this trial. Exclusion Criteria: * Secodary hyertension due to other causes. * History of depression,schizophrenia or vascular dementia . * History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. * Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. * Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. * Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. * Fertile woman without contraceptives. * Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs. * Allergic to or have contraindication to the contrast agents and alcohol.

Outcomes

Primary Outcomes

Change of office systolic blood ptressure

Change of office systolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Secondary Outcomes

Change of office dystolic blood pressure

Change of office dystolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of home systolic blood pressure

Change of home systolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of home diastolic blood pressure

Change of home diastolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of 24-h average systolic blood pressure

Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of 24-h average diastolic blood pressure

Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of DDD of anti-hypertensive regimen

Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of plasma adrenal hormones

Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of plasma renin levels

Change of plasma renin levels compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of blood electrolytes

Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.

Time frame: 24 weeks

Change of serum creatinine

Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.

Time frame: 24 weeks

Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes