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Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

Primary Purpose

Resistant Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Adrenal Artery Ablation
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring resistant hypertension; aldosteronism

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female, age between 30-65 years old.
  • Primary aldosteronism with resistant hypertension.
  • Informed consent signed and agreed to participate in this trial.

Exclusion Criteria:

  • Secodary hyertension due to other causes.
  • History of depression,schizophrenia or vascular dementia .
  • History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
  • Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
  • Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
  • Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
  • Fertile woman without contraceptives.
  • Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
  • Allergic to or have contraindication to the contrast agents and alcohol.

Sites / Locations

  • The third hospital affiliated to the Third Military Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervension

Arm Description

Adrenal artery ablation is performed in PA patients with resistant hypertension.

Outcomes

Primary Outcome Measures

Change of office systolic blood ptressure
Change of office systolic blood pressure compared with baseline after 24 weeks.

Secondary Outcome Measures

Change of office dystolic blood pressure
Change of office dystolic blood pressure compared with baseline after 24 weeks.
Change of home systolic blood pressure
Change of home systolic blood pressure compared with baseline after 24 weeks.
Change of home diastolic blood pressure
Change of home diastolic blood pressure compared with baseline after 24 weeks.
Change of 24-h average systolic blood pressure
Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.
Change of 24-h average diastolic blood pressure
Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.
Change of DDD of anti-hypertensive regimen
Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.
Change of plasma adrenal hormones
Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.
Change of plasma renin levels
Change of plasma renin levels compared with baseline after 24 weeks.
Change of blood electrolytes
Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.
Change of serum creatinine
Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.

Full Information

First Posted
April 5, 2020
Last Updated
April 11, 2020
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04345198
Brief Title
Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension
Official Title
Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
October 15, 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 the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them 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 cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized. With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistant Hypertension
Keywords
resistant hypertension; aldosteronism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervension
Arm Type
Experimental
Arm Description
Adrenal artery ablation is performed in PA patients with resistant hypertension.
Intervention Type
Procedure
Intervention Name(s)
Adrenal Artery Ablation
Intervention Description
Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.
Primary Outcome Measure Information:
Title
Change of office systolic blood ptressure
Description
Change of office systolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change of office dystolic blood pressure
Description
Change of office dystolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of home systolic blood pressure
Description
Change of home systolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of home diastolic blood pressure
Description
Change of home diastolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of 24-h average systolic blood pressure
Description
Change of 24-h average systolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of 24-h average diastolic blood pressure
Description
Change of 24-h average diastolic blood pressure compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of DDD of anti-hypertensive regimen
Description
Change of Defined Daily Dose (DDD) of anti-hypertensive regimen compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of plasma adrenal hormones
Description
Change of plasma aldosterone and cortisol compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of plasma renin levels
Description
Change of plasma renin levels compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of blood electrolytes
Description
Change of serum potassium, natrium, and chlorine compared with baseline after 24 weeks.
Time Frame
24 weeks
Title
Change of serum creatinine
Description
Change of serum creatinine measured as umol/L compared with baseline after 24 weeks.
Time Frame
24 weeks

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: Male or female, age between 30-65 years old. Primary aldosteronism with resistant hypertension. Informed consent signed and agreed to participate in this trial. Exclusion Criteria: Secodary hyertension due to other causes. History of depression,schizophrenia or vascular dementia . History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. Fertile woman without contraceptives. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs. Allergic to or have contraindication to the contrast agents and alcohol.
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Adrenal Artery Ablation for Primary Aldosteronism With Resistant Hypertension

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