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Adrenal Artery Ablation for Primary Aldosteronism

Primary Purpose

Primary Aldosteronism, Hypertension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Endovascular chemical Ablation of Adrenal Gland
Sequenced antihypertensvie drugs with titrated dosage
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring Hypertension, Primary Aldosteronism, Ablation, Adrenal Gland

Eligibility Criteria

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

Inclusion Criteria:

  • Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
  • Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
  • The patients were diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
  • Signed informed consent and agreed to participate in this study.

Exclusion Criteria:

  • Aldosterone cancer.
  • Hyperkalemia.
  • Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
  • Secondary hypertension except the primary aldosteronism.
  • 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.
  • 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
  • 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

Intevention

Control

Arm Description

Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg.

Patients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg.

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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.

Secondary Outcome Measures

Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial
Difference in the change of blood electrolytes（serum potassium and natrium in mmol/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of plasma aldosterone and 24-h urine aldosterone measured at baseline and the end of the trial
Difference in the change of plasma aldosterone and 24-h urine aldosterone compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of 24-h average systolic blood pressure measured at the end of the trial 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 assessed at baseline and the end of the trial
Difference in the change of anti-hypertensive regimen compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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) compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of fasting blood glucose and lipids profiles measured at baseline and the end of the trial
Difference in the change of fasting blood glucose and lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of sex hormones measured at baseline and the end of the trial
Difference in the change of 17-OH, DHEAS, testosterone and estrogen levels compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) measured at baseline and the end of the trial
Difference in the change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre(mm), and LVEF(%), LVM in gram) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
Difference in the change of carotid intima-media thickness(CIMT) in millimetre(mm) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.

Full Information

First Posted
June 7, 2018
Last Updated
August 28, 2018
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03653845
Brief Title
Adrenal Artery Ablation for Primary Aldosteronism
Official Title
Adrenal Artery Ablation for Primary Aldosteronism：A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary aldosteronism (PA) is one of the most common causes of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages. The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions. Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism, Hypertension
Keywords
Hypertension, Primary Aldosteronism, 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
Intevention
Arm Type
Experimental
Arm Description
Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg.
Intervention Type
Procedure
Intervention Name(s)
Endovascular chemical Ablation of Adrenal Gland
Intervention Description
Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
Intervention Type
Drug
Intervention Name(s)
Sequenced antihypertensvie drugs with titrated dosage
Intervention Description
Patients will be treated with different antihypertensive drugs in two groups.
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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial
Description
Difference in the change of blood electrolytes（serum potassium and natrium in mmol/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of plasma aldosterone and 24-h urine aldosterone measured at baseline and the end of the trial
Description
Difference in the change of plasma aldosterone and 24-h urine aldosterone compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of 24-h average systolic blood pressure measured at the end of the trial 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 assessed at baseline and the end of the trial
Description
Difference in the change of anti-hypertensive regimen compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) 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) compared with the baseline at the end of the study (24 weeks) 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of fasting blood glucose and lipids profiles measured at baseline and the end of the trial
Description
Difference in the change of fasting blood glucose and lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial
Description
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks
Title
Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) 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) compared with the baseline at the end of the study (24 weeks) 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) in millimetre(mm) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Time Frame
24 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test. Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS). The patients were diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision. Signed informed consent and agreed to participate in this study. Exclusion Criteria: Aldosterone cancer. Hyperkalemia. Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome. Secondary hypertension except the primary aldosteronism. 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. 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.
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD
Phone
86-023-68705094
Email
zhuzm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Adrenal Artery Ablation for Primary Aldosteronism

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