Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

NCT ID: NCT04345198

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-10-15

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.

Conditions

Resistant Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervension

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

Group Type: EXPERIMENTAL

Adrenal Artery Ablation

Intervention Type: PROCEDURE

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

Interventions

Adrenal Artery Ablation

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The third hospital affiliated to the Third Military Medical University

Chongqing, , China

Countries

China

Other Identifiers

AAA-RHT

Identifier Type: -

Identifier Source: org_study_id