Adrenal Artery Ablation for Uncontrolled Hypertension

NCT03660397 | Unknown Phase 3

• 1 other identifier: AAA-UHT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Uncontrolled Hypertension; Resistant hypertension; Aldosterone; Ablation; Adrenal Gland

Outcome Measures

Primary Outcomes (1)

• Change of 24-h average systolic blood pressure measured at baseline and the end of the trial

  Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed.

  24 weeks

Secondary Outcomes (12)

• Change of 24-h average systolic blood pressure compared with the baseline

  24 weeks

• Change of anti-hypertensive regimen measured at baseline and the end of the trial

  24 weeks

• Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measured at baseline and the end of the trial

  24 weeks

• Change of home systolic and diastolic pressure measured at baseline and the end of the trial

  24 weeks

• Change of office systolic and diastolic pressure measured at baseline and the end of the trial

  24 weeks

Other Outcomes (4)

• Change of sex hormones measured at baseline and the end of the trial

  24 weeks

• Change of 24-h urine microalbumin measured at baseline and the end of the trial

  24 weeks

• Change of echocardiography measured at baseline and the end of the trial

  24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Selective endovascular chemical ablation of adrenal gland after adrenal angiography.

Procedure: Selective endovascular chemical ablation of adrenal gland; Drug: Traditional triple antihypertensive treatment

Control

ACTIVE COMPARATOR

No intervention, but treated with standard antihypertensive drugs

Drug: Traditional triple antihypertensive treatment

Interventions

Selective endovascular chemical ablation of adrenal gland PROCEDURE

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

Intervention

Traditional triple antihypertensive treatment DRUG

irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d

Control; Intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: September 6, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

CN (1)