Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

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

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 Overview

• Status: Completed
• Conditions: Resistant Hypertension
• Intervention / Treatment: Procedure: Adrenal Artery Ablation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400042
    • The third hospital affiliated to the Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of office systolic blood ptressure	Change of office systolic blood pressure compared with baseline after 24 weeks.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of office dystolic blood pressure	Change of office dystolic blood pressure compared with baseline after 24 weeks.	24 weeks
Change of home systolic blood pressure	Change of home systolic blood pressure compared with baseline after 24 weeks.	24 weeks
Change of home diastolic blood pressure	Change of home diastolic blood pressure compared with baseline after 24 weeks.	24 weeks
Change of 24-h average systolic blood pressure	Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.	24 weeks
Change of 24-h average diastolic blood pressure	Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.	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.	24 weeks
Change of plasma adrenal hormones	Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.	24 weeks
Change of plasma renin levels	Change of plasma renin levels compared with baseline after 24 weeks.	24 weeks
Change of blood electrolytes	Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.	24 weeks
Change of serum creatinine	Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.	24 weeks

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: resistant hypertension; aldosteronism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hypertension; Hyperaldosteronism; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: AAA-RHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No