Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Sponsor

Third Military Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04345198

Collaborator

(none)

Enrollment

Location

Arm

24.4

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resistant Hypertension	Procedure: Adrenal Artery Ablation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Apr 15, 2019

Actual Study Completion Date :

Oct 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervension Adrenal artery ablation is performed in PA patients with resistant hypertension.	Procedure: Adrenal Artery Ablation Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.

Arm

Intervention/Treatment

Experimental: Intervension

Adrenal artery ablation is performed in PA patients with resistant hypertension.

Procedure: Adrenal Artery Ablation

Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change of office dystolic blood pressure [24 weeks]
Change of office dystolic blood pressure compared with baseline after 24 weeks.
Change of home systolic blood pressure [24 weeks]
Change of home systolic blood pressure compared with baseline after 24 weeks.
Change of home diastolic blood pressure [24 weeks]
Change of home diastolic blood pressure compared with baseline after 24 weeks.
Change of 24-h average systolic blood pressure [24 weeks]
Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.
Change of 24-h average diastolic blood pressure [24 weeks]
Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.
Change of DDD of anti-hypertensive regimen [24 weeks]
Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.
Change of plasma adrenal hormones [24 weeks]
Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.
Change of plasma renin levels [24 weeks]
Change of plasma renin levels compared with baseline after 24 weeks.
Change of blood electrolytes [24 weeks]
Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.
Change of serum creatinine [24 weeks]
Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.