Adrenal Artery Ablation for Uncontrolled Hypertension

NCT ID: NCT03660397

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-01

Brief Summary

The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS 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 causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.

With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.

Conditions

Uncontrolled Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Selective endovascular chemical ablation of adrenal gland after adrenal angiography.

Group Type: EXPERIMENTAL

Selective endovascular chemical ablation of adrenal gland

Intervention Type: PROCEDURE

Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group.

Traditional triple antihypertensive treatment

Intervention Type: DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Control

No intervention, but treated with standard antihypertensive drugs

Group Type: ACTIVE_COMPARATOR

Traditional triple antihypertensive treatment

Intervention Type: DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Interventions

Selective endovascular chemical ablation of adrenal gland

Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group.

Intervention Type: PROCEDURE

Traditional triple antihypertensive treatment

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female, aged between 30-60 years old.
• Patients with poorly controlled hypertension (office blood pressure ≥130/80 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks
• Positional blood aldosterone ≥100pg/ml.
• Informed consent signed and agreed to participate in this trial.

Exclusion Criteria

• Hyperkalemia or hypokalemia.
• Secondary hypertension.
• History of depression, schizophrenia or vascular dementia.
• Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
• Adrenergic insufficiency.
• Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
• Acute infections, tumors and severe arrhythmias, psychiatric disorders,
• drugs or alcohol addicts.
• Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
• Fertile woman without contraceptives.
• Coagulation dysfunction.
• Pregnant women or lactating women.
• Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
• Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
• Allergy or any contraindications for the study drugs, contrast agents and alcohol.
• Refused to sign informed consent

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Director of the Department of Hypertension & Endocrinology, Daping Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Hongbo He, MD.

Role: primary

cqhehongbo@gmail.com

86-23-68757880

Other Identifiers

AAA-UHT

Identifier Type: -

Identifier Source: org_study_id