Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Resistant Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345198
• Other study ID #: AAA-RHT
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: April 2020
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Resistant Hypertension

Intervention

Procedure:
• Adrenal Artery Ablation
Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

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