Clinical trial NCT04345198: Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension
Official title: Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Hypertension
Keywords: resistant hypertension; aldosteronism
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of office systolic blood ptressure
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of office dystolic blood pressure
timeFrame: 24 weeks
measure: Change of home systolic blood pressure
timeFrame: 24 weeks
measure: Change of home diastolic blood pressure
timeFrame: 24 weeks
measure: Change of 24-h average systolic blood pressure
timeFrame: 24 weeks
measure: Change of 24-h average diastolic blood pressure
timeFrame: 24 weeks
measure: Change of DDD of anti-hypertensive regimen
timeFrame: 24 weeks
measure: Change of plasma adrenal hormones
timeFrame: 24 weeks
measure: Change of plasma renin levels
timeFrame: 24 weeks
measure: Change of blood electrolytes
timeFrame: 24 weeks
measure: Change of serum creatinine
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
Study officials:
References: