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Adrenal Artery Ablation Treats Primary Aldosteronism

Primary Purpose

Primary Aldosteronism, Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Endovascular chemical Ablation of Adrenal Gland
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 Primary Aldosteronism, Hypertension, 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 was 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 2 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 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intevention

Control

Arm Description

Adrenal Artery Ablation

No intervention, but treated with standard anti-hypertensive drigs

Outcomes

Primary 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.

Secondary Outcome Measures

Change of 24-h average systolic blood pressure between two groups
Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Change of anti-hypertensive regimen between two groups
Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (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 between two groups
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 at the end of the study (24 weeks)
Change of office systolic and diastolic pressure between two groups
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Change of blood electrolytes（serum potassium and natrium in mmol/L）
Change of blood electrolytes（serum potassium and natrium in mmol/L） compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of plasma aldosterone and 24-h urine aldosterone
Change of plasma aldosterone and 24-h urine aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of plasma renin
Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of plasma cortisol and 24-h urine cortisol
Change of plasma cortisol and 24-h urine cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of liver enzymes (ALT, AST)
Change of liver enzymes (ALT, AST) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of serum creatinine
Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of fasting blood glucose
Change of fasting blood glucose in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)

Full Information

First Posted
December 24, 2017
Last Updated
July 3, 2019
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03398785
Brief Title
Adrenal Artery Ablation Treats Primary Aldosteronism
Official Title
An Open-label, Prospective, Controlled Clinical Trial on Effects and Safety of Adrenal Artery Ablation (Triple A) for Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

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
Primary aldosteronism (PA) is one of the most common cause 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
Primary Aldosteronism, Hypertension, Ablation, Adrenal Gland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with conventional anti-hypertensive drugs
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intevention
Arm Type
Experimental
Arm Description
Adrenal Artery Ablation
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention, but treated with standard anti-hypertensive drigs
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.
Primary 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
Secondary Outcome Measure Information:
Title
Change of 24-h average systolic blood pressure between two groups
Description
Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of anti-hypertensive regimen between two groups
Description
Change of number, classes, and combinations of classes of antihypertensive drugs between the intervention and control group at the end of the study (24 weeks)
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 between two groups
Description
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 at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of office systolic and diastolic pressure between two groups
Description
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of blood electrolytes（serum potassium and natrium in mmol/L）
Description
Change of blood electrolytes（serum potassium and natrium in mmol/L） compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of plasma aldosterone and 24-h urine aldosterone
Description
Change of plasma aldosterone and 24-h urine aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of plasma renin
Description
Change of plasma renin compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of plasma cortisol and 24-h urine cortisol
Description
Change of plasma cortisol and 24-h urine cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of liver enzymes (ALT, AST)
Description
Change of liver enzymes (ALT, AST) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of serum creatinine
Description
Change of serum creatinine compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of fasting blood glucose
Description
Change of fasting blood glucose in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Description
Change of lipids profiles (Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Change of testosterone and estrogen levels
Description
Change of testosterone and estrogen levels compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of 24-h urine microalbumin, microalbumin/creatinine ratio
Description
Change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM)
Description
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of carotid intima-media thickness assessed by carotid ultrasound
Description
Change of carotid intima-media thickness(CIMT) assessed by carotid ultrasound compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks
Title
Change of electrocardiogram manifestations
Description
Change of electrocardiogram manifestations(heart rhythms, heart rates and arrhythmia ) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
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: 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 was 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 2 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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34059026
Citation
Sun F, Hong Y, Zhang H, Liu X, Zhao Z, He H, Yan Z, Zhu Z. Determination of adrenal hypersecretion in primary Aldosteronism without aldosterone-production adenomas. BMC Endocr Disord. 2021 May 31;21(1):114. doi: 10.1186/s12902-021-00770-1.
Results Reference
derived

Learn more about this trial

Adrenal Artery Ablation Treats Primary Aldosteronism

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