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The Effect of SAAE on Ventricular Remodeling in PA Patients

Primary Purpose

Primary Aldosteronism

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Super selective adrenal artery embolization
Spironolactone
Sponsored by
Second Affiliated Hospital of Nanchang 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, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling

Eligibility Criteria

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

Inclusion Criteria:

  • (1) Age 18-60 years old, regardless of gender;
  • (2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg;
  • (3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling;
  • (4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization;
  • (5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening.

Exclusion Criteria:

  • (1) Primary hypertension or secondary hypertension with other causes;
  • (2) A woman who is pregnant or lactating, or has a birth plan for the next year;
  • (3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR<45 mL/min/1.73 m2);
  • (4) Severe allergy to contrast medium;
  • (5) Other serious organic diseases, life expectancy < 12 months;
  • (6) Adrenal CT showed adenoma.;
  • (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.

Sites / Locations

  • The Second Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAAE group

Spironolactone group

Arm Description

Subjects received super selective adrenal artery embolization treatment

Subjects received spironolactone treatment

Outcomes

Primary Outcome Measures

LVMI
Left ventricular mass index(LVMI)

Secondary Outcome Measures

LVH
left ventricular hypertrophy
ABPM
24-hour ambulatory blood pressure monitor
ABPM
24-hour ambulatory blood pressure monitor
PAC
plasma aldosterone concentration
PAC
plasma aldosterone concentration
PRA
plasma renin activity
PRA
plasma renin activity
ARR
aldosterone-to-renin ratio
ARR
aldosterone-to-renin ratio
Serum potassium
Serum potassium
Serum potassium
Serum potassium
serum creatinine
serum creatinine
serum creatinine
serum creatinine

Full Information

First Posted
August 12, 2022
Last Updated
September 16, 2022
Sponsor
Second Affiliated Hospital of Nanchang University
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1. Study Identification

Unique Protocol Identification Number
NCT05501080
Brief Title
The Effect of SAAE on Ventricular Remodeling in PA Patients
Official Title
The Effect of Selective Adrenal Artery Embolization and Spironolactone on Ventricular Remodeling in Nondominant Lateral Secretory Primary Aldosteronism： A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.
Detailed Description
After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
primary aldosteronism, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAAE group
Arm Type
Experimental
Arm Description
Subjects received super selective adrenal artery embolization treatment
Arm Title
Spironolactone group
Arm Type
Active Comparator
Arm Description
Subjects received spironolactone treatment
Intervention Type
Other
Intervention Name(s)
Super selective adrenal artery embolization
Intervention Description
Superselective adrenal arterial embolization is an operation to inject embolic agent into adrenal artery through catheter to embolize part of adrenal gland, so as to reduce the secretion of adrenal hormone and reduce blood pressure.
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.
Primary Outcome Measure Information:
Title
LVMI
Description
Left ventricular mass index(LVMI)
Time Frame
12 months after SAAE
Secondary Outcome Measure Information:
Title
LVH
Description
left ventricular hypertrophy
Time Frame
12 months after SAAE
Title
ABPM
Description
24-hour ambulatory blood pressure monitor
Time Frame
1 month after SAAE
Title
ABPM
Description
24-hour ambulatory blood pressure monitor
Time Frame
12 months after SAAE
Title
PAC
Description
plasma aldosterone concentration
Time Frame
1 month after SAAE
Title
PAC
Description
plasma aldosterone concentration
Time Frame
12 months after SAAE
Title
PRA
Description
plasma renin activity
Time Frame
1 month after SAAE
Title
PRA
Description
plasma renin activity
Time Frame
12 months after SAAE
Title
ARR
Description
aldosterone-to-renin ratio
Time Frame
1 month after SAAE
Title
ARR
Description
aldosterone-to-renin ratio
Time Frame
12 months after SAAE
Title
Serum potassium
Description
Serum potassium
Time Frame
1 month after SAAE
Title
Serum potassium
Description
Serum potassium
Time Frame
12 months after SAAE
Title
serum creatinine
Description
serum creatinine
Time Frame
1 month after SAAE
Title
serum creatinine
Description
serum creatinine
Time Frame
12 months after SAAE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Age 18-60 years old, regardless of gender; (2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure > 130/80 mmHg or daytime blood pressure > 135/85 mmHg; (3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling; (4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization; (5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening. Exclusion Criteria: (1) Primary hypertension or secondary hypertension with other causes; (2) A woman who is pregnant or lactating, or has a birth plan for the next year; (3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR<45 mL/min/1.73 m2); (4) Severe allergy to contrast medium; (5) Other serious organic diseases, life expectancy < 12 months; (6) Adrenal CT showed adenoma.; (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yifei Dong, Doctorate
Phone
+8613576007061
Email
yf_dong66@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifei Dong, Doctorate
Organizational Affiliation
Second Affiliated Hospital of Nanchang University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of SAAE on Ventricular Remodeling in PA Patients

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