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Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

Primary Purpose

Primary Aldosteronism, Hypertension

Status
Unknown status
Phase
Not Applicable
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, Adrenal Artery Ablation, Adrenalectomy

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary aldosteronis diagnosed by increased aldosterone-to-renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
  • Aldosteronoma had lateralization by adrenal venous sampling (AVS) and confirmed with CT
  • 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 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.
  • Allergy or any contraindications for contrast agents and alcohol.
  • Refused to sign informed consent

Sites / Locations

  • The third hospital affiliated to the Army Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adrenal Artery Ablation

Adrenalectomy

Arm Description

Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol

Patients in this group will be treated with unilateral laparoscopic adrenalectomy

Outcomes

Primary Outcome Measures

Change of office systolic and diastolic pressure
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)

Secondary Outcome Measures

Change of 24-h average systolic blood pressure
Change of 24-h average systolic blood pressure between the intervention and control group at the end of the study (24 weeks)
Change of 24-h average diastolic blood pressure
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 home systolic and diastolic pressure
Change of home systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Change of anti-hypertensive regimen
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 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)between the intervention and control group at the end of the study (24 weeks)
Change of aldosterone-to-renin ratio (ARR）
Change of aldosterone-to-renin ratio (ARR）compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of plasma aldosterone
Change of plasma 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
Change of plasma cortisol 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 estimated glomerular filtration rate(eGFR)
Change of estimated glomerular filtration rate(eGFR) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Change of 24-h urine microalbumin, microalbumin/creatinine ratio
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)

Full Information

First Posted
February 12, 2020
Last Updated
February 8, 2021
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04269928
Brief Title
Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
Official Title
An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
June 30, 2021 (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
Primary aldosteronism (PA) is the main cause of secondary hypertension, affecting 5-15% of the general hypertensive population. Early diagnosis and treatment are of crucial importance as patients with PA are more susceptible to cardiovascular and cerebrovascular morbidity and mortality than blood-pressure-matched hypertensive patients. Current guidelines indicate that mineralocorticoid receptor (MR) antagonists and laparoscopic adrenalectomy are the principal treatments for PA.Laparoscopic adrenalectomy is recommended for patients with aldosteronoma or unilateral adrenal hyperplasia. During the past two decades, catheter-based arterial embolization or computed tomography (CT)-guided radiofrequency thermogenesis have been used for aldosteronomas treatment. Although these procedures are claimed to be effective for treatment of aldosteronomas, the evidence comes mostly from case reports or small series. In addition, some PA patients refuse surgery and are intolerant of the adverse effects of MR antagonists; others have persistence of PA after adrenelectomy, but respond poorly to MR antagonists. An alternative therapy is needed in such cases. In recent years, adrenal artery ablation has also been used to treat primary aldosteronism, which can reduce the level of aldosterone and blood pressure, but its efficacy and safety are not clear. To confirm the effect of adrenal artery ablation on blood pressure, RAAS system and blood potassium, the researchers conducted a parallel control clinical study of patients with primary aldosteronism (Aldosteronoma).

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, Adrenal Artery Ablation, Adrenalectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All patients were assigned to two parallel groups by 2:1 ratio. 40 patients in the Intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol. The other 20 patients in the Control group will be treated with unilateral laparoscopic adrenalectomy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adrenal Artery Ablation
Arm Type
Experimental
Arm Description
Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
Arm Title
Adrenalectomy
Arm Type
No Intervention
Arm Description
Patients in this group will be treated with unilateral laparoscopic adrenalectomy
Intervention Type
Procedure
Intervention Name(s)
Endovascular chemical ablation of adrenal gland
Intervention Description
Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
Primary Outcome Measure Information:
Title
Change of office systolic and diastolic pressure
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 (End of Trial)
Secondary Outcome Measure Information:
Title
Change of 24-h average systolic blood pressure
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 (End of Trial)
Title
Change of 24-h average diastolic blood pressure
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 (End of Trial)
Title
Change of home systolic and diastolic pressure
Description
Change of home systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
Title
Change of anti-hypertensive regimen
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 (End of Trial)
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)between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
Title
Change of aldosterone-to-renin ratio (ARR）
Description
Change of aldosterone-to-renin ratio (ARR）compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
Title
Change of plasma aldosterone
Description
Change of plasma aldosterone compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
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 (End of Trial)
Title
Change of plasma cortisol
Description
Change of plasma cortisol compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
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 (End of Trial)
Title
Change of estimated glomerular filtration rate(eGFR)
Description
Change of estimated glomerular filtration rate(eGFR) compared with baseline, and between the intervention and control group at the end of the study (24 weeks)
Time Frame
24 weeks (End of Trial)
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 (End of Trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary aldosteronis diagnosed by increased aldosterone-to-renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test. Aldosteronoma had lateralization by adrenal venous sampling (AVS) and confirmed with CT 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 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. Allergy or any contraindications for contrast agents and alcohol. Refused to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yingsha, MD
Phone
13594659454
Ext
68
Email
yslimiss@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu ZM, MD
Phone
68767848
Ext
68-023
Email
zhuzm@yahoo.com
Facility Information:
Facility Name
The third hospital affiliated to the Army 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
Zhu ZM, MD
Phone
68767848
Ext
68-023
Email
zhuzm@yahoo.com
First Name & Middle Initial & Last Name & Degree
Li Yingsha, MD
Phone
13594659454
Email
yslimiss@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism

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