Primary AldosteronismNCT05501080
The Effect of SAAE on Ventricular Remodeling in PA Patients
A study testing Super selective adrenal artery embolization and Spironolactone in people with Primary Aldosteronism, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Super selective adrenal artery embolization and Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
About this study
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
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.
Read the 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.
- Conditions
- Primary Aldosteronism
- Being tested
- Super selective adrenal artery embolization, Spironolactone
- Keywords
- primary aldosteronism, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling
- Medical subject headings
- Hyperaldosteronism, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super selective adrenal artery embolizationOther
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.
SpironolactoneDrug
Aldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism.
| Study group | Role | What they receive |
|---|---|---|
| SAAE group | Experimental | Subjects received super selective adrenal artery embolization treatment Receives: Other: Super selective adrenal artery embolization |
| Spironolactone group | Active comparator | Subjects received spironolactone treatment Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVMI
Left ventricular mass index(LVMI)
Measured: 12 months after SAAE
Secondary outcomes (13)
LVH
left ventricular hypertrophy
Measured: 12 months after SAAE
ABPM
24-hour ambulatory blood pressure monitor
Measured: 1 month after SAAE
ABPM
24-hour ambulatory blood pressure monitor
Measured: 12 months after SAAE
PAC
plasma aldosterone concentration
Measured: 1 month after SAAE
PAC
plasma aldosterone concentration
Measured: 12 months after SAAE
PRA
plasma renin activity
Measured: 1 month after SAAE
PRA
plasma renin activity
Measured: 12 months after SAAE
ARR
aldosterone-to-renin ratio
Measured: 1 month after SAAE
ARR
aldosterone-to-renin ratio
Measured: 12 months after SAAE
Serum potassium
Serum potassium
Measured: 1 month after SAAE
Serum potassium
Serum potassium
Measured: 12 months after SAAE
serum creatinine
serum creatinine
Measured: 1 month after SAAE
serum creatinine
serum creatinine
Measured: 12 months after SAAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifei Dong, Second Affiliated Hospital of Nanchang University
- Investigators
- Yifei Dong, Doctorate, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501080
- Sponsor's protocol ID
- IIT-2022-073
- Status last verified
- May 2025
- First submitted
- 12 Aug 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05501080
- Acronym / sponsor ID
- IIT-2022-073
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, selective adrenal artery embolization, bilateral primary aldosteronism, Nondominant Lateral Secretory Primary Aldosteronism, Ventricular Remodeling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAAE group | Experimental | Other: Super selective adrenal artery embolizationSubjects received super selective adrenal artery embolization treatment |
| Spironolactone group | Active comparator | Drug: SpironolactoneSubjects received spironolactone treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (7 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super selective adrenal artery embolizationSuperselective 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. | Other | SAAE group |
| SpironolactoneAldosterone receptor antagonists are recommended by guidelines for the treatment of bilateral primary aldosteronism. | Drug | Spironolactone group |
Primary outcome
LVMI
Time frame: 12 months after SAAE
Left ventricular mass index(LVMI)
13 secondary outcomes
LVH
Time frame: 12 months after SAAE
ABPM
Time frame: 1 month after SAAE
ABPM
Time frame: 12 months after SAAE
PAC
Time frame: 1 month after SAAE
PAC
Time frame: 12 months after SAAE
PRA
Time frame: 1 month after SAAE
PRA
Time frame: 12 months after SAAE
ARR
Time frame: 1 month after SAAE
ARR
Time frame: 12 months after SAAE
Serum potassium
Time frame: 1 month after SAAE
Serum potassium
Time frame: 12 months after SAAE
serum creatinine
Time frame: 1 month after SAAE
serum creatinine
Time frame: 12 months after SAAE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yifei Dong, Doctorate study director
Second Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super selective adrenal artery embolization and Spironolactone in people with Primary Aldosteronism, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifei Dong, Doctorate (+8613576007061, yf_dong66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVMI (time frame: 12 months after SAAE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.