Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Not Applicable

Completed

• Conditions: Resistant Hypertension
• Interventions: Procedure: Adrenal Artery Ablation

• Registration Number: NCT04345198
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-04-15
• Study Completion: 2019-10-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-11
• Last Update Submitted: 2020-04-11
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervension	Adrenal Artery Ablation	Adrenal artery ablation is performed in PA patients with resistant hypertension.

Primary Outcome Measures

Name	Time	Method
Change of office systolic blood ptressure	24 weeks	Change of office systolic blood pressure compared with baseline after 24 weeks.

Secondary Outcome Measures

Name	Time	Method
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 24-h average diastolic blood pressure	24 weeks	Change of 24-h average diastolic blood pressure 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 serum creatinine	24 weeks	Change of serum creatinine measured as umol/L 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 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 blood electrolytes	24 weeks	Change of serum potassium, natrium, and chlorine 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.

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, China