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Adrenal Artery Ablation for Uncontrolled Hypertension

Primary Purpose

Uncontrolled Hypertension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Selective endovascular chemical ablation of adrenal gland
Traditional triple antihypertensive treatment
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Uncontrolled Hypertension, Resistant hypertension, Aldosterone, Ablation, Adrenal Gland

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The third hospital affiliated to the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Selective endovascular chemical ablation of adrenal gland after adrenal angiography.

No intervention, but treated with standard antihypertensive drugs

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of 24-h average systolic blood pressure compared with the baseline
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Change of anti-hypertensive regimen measured at baseline and the end of the trial
Difference in the change of anti-hypertensive regimen between the intervention and control group is to be analysed.
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
Difference in the 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 between the intervention and control group is to be analysed.
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of home systolic and diastolic pressure between the intervention and control group is to be analysed.
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of office systolic and diastolic pressure between the intervention and control group is to be analysed.
Change of blood electrolytes measured at baseline and the end of the trial
Difference in the change of blood electrolytes between the intervention and control group is to be analysed.
Change of plasma and urine adrenal hormones measured at baseline and the end of the trial
Difference in the change of plasma and urine adrenal hormones between the intervention and control group is to be analysed.
Change of plasma renin measured at baseline and the end of the trial
Difference in the change of plasma renin between the intervention and control group is to be analysed.
Change of liver enzymes measured at baseline and the end of the trial
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group is to be analysed.
Change of kidney function measured at baseline and the end of the trial
Difference in the change of serum creatinine in umol/L between the intervention and control group is to be analysed.
Change of fasting blood glucose measured at baseline and the end of the trial
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group is to be analysed.
Change of lipids profiles measured at baseline and the end of the trial
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group is to be analysed.

Full Information

First Posted
June 7, 2018
Last Updated
September 4, 2018
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03660397
Brief Title
Adrenal Artery Ablation for Uncontrolled Hypertension
Official Title
Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Uncontrolled Hypertension: A Randomized, Parallel, Active-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension
Keywords
Uncontrolled Hypertension, Resistant hypertension, Aldosterone, Ablation, Adrenal Gland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Selective endovascular chemical ablation of adrenal gland after adrenal angiography.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No intervention, but treated with standard antihypertensive drugs
Intervention Type
Procedure
Intervention Name(s)
Selective endovascular chemical ablation of adrenal gland
Intervention Description
Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group.
Intervention Type
Drug
Intervention Name(s)
Traditional triple antihypertensive treatment
Intervention Description
irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
Primary Outcome Measure Information:
Title
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
Description
Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change of 24-h average systolic blood pressure compared with the baseline
Description
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Time Frame
24 weeks
Title
Change of anti-hypertensive regimen measured at baseline and the end of the trial
Description
Difference in the change of anti-hypertensive regimen between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
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
Description
Difference in the 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 between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Description
Difference in the change of home systolic and diastolic pressure between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Description
Difference in the change of office systolic and diastolic pressure between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of blood electrolytes measured at baseline and the end of the trial
Description
Difference in the change of blood electrolytes between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of plasma and urine adrenal hormones measured at baseline and the end of the trial
Description
Difference in the change of plasma and urine adrenal hormones between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of plasma renin measured at baseline and the end of the trial
Description
Difference in the change of plasma renin between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of liver enzymes measured at baseline and the end of the trial
Description
Difference in the change of liver enzymes (ALT, AST in IU/L) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of kidney function measured at baseline and the end of the trial
Description
Difference in the change of serum creatinine in umol/L between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of fasting blood glucose measured at baseline and the end of the trial
Description
Difference in the change of fasting blood glucose in mmol/L between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of lipids profiles measured at baseline and the end of the trial
Description
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L between the intervention and control group is to be analysed.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Change of sex hormones measured at baseline and the end of the trial
Description
Difference in the change of 17-OH, DHEAS, testosterone and estrogen levels between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of 24-h urine microalbumin measured at baseline and the end of the trial
Description
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of echocardiography measured at baseline and the end of the trial
Description
Difference in the change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre(mm), and LVEF(%), LVM in gram) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
Description
Difference in the change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound between the intervention and control group is to be analysed.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo He, MD.
Phone
86-23-68757880
Email
cqhehongbo@gmail.com
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD.

12. IPD Sharing Statement

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Adrenal Artery Ablation for Uncontrolled Hypertension

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