Primary AldosteronismNCT04269928
Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
An observational study of Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- Endovascular chemical ablation of adrenal gland
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2016to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The third hospital affiliated to the Army Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
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).
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- Endovascular chemical ablation of adrenal gland
- Keywords
- Primary Aldosteronism, Hypertension, Adrenal Artery Ablation, Adrenalectomy
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular chemical ablation of adrenal glandProcedure or surgery
Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
| Study group | Role | What they receive |
|---|---|---|
| Adrenal Artery Ablation | Patients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol Receives: Procedure: Endovascular chemical ablation of adrenal gland | |
| Adrenalectomy | Patients in this group will be treated with unilateral laparoscopic adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 52 weeks (End of Trial)
Secondary outcomes (12)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
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)
Measured: 52 weeks (End of Trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start19 Jan 2016
- Primary completion30 Dec 2019
- Study completion1 Jun 2021
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269928
- Sponsor's protocol ID
- Quadruple A -PA
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Parallel Control Clinical Trail on Effects of Adrenal Artery Ablation and Adrenalectomy in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT04269928
- Acronym / sponsor ID
- Quadruple A -PA
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- Primary Aldosteronism, Hypertension, Adrenal Artery Ablation, Adrenalectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 17 Feb 2020 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenal Artery Ablation | – | Procedure: Endovascular chemical ablation of adrenal glandPatients in the intervention group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol |
| Adrenalectomy | – | –Patients in this group will be treated with unilateral laparoscopic adrenalectomy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Endovascular chemical ablation of adrenal glandPatients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol | Procedure or surgery | Adrenal Artery Ablation |
Primary outcome
Change of office systolic and diastolic pressure
Time frame: 52 weeks (End of Trial)
Change of office systolic and diastolic pressure between the intervention and control group at the end of the study (24 weeks)
12 secondary outcomes
Change of 24-h average systolic blood pressure
Time frame: 52 weeks (End of Trial)
Change of 24-h average diastolic blood pressure
Time frame: 52 weeks (End of Trial)
Change of home systolic and diastolic pressure
Time frame: 52 weeks (End of Trial)
Change of anti-hypertensive regimen
Time frame: 52 weeks (End of Trial)
Change of blood electrolytes（serum potassium and natrium in mmol/L）
Time frame: 52 weeks (End of Trial)
Change of aldosterone-to-renin ratio (ARR）
Time frame: 52 weeks (End of Trial)
Change of plasma aldosterone
Time frame: 52 weeks (End of Trial)
Change of plasma renin
Time frame: 52 weeks (End of Trial)
Change of plasma cortisol
Time frame: 52 weeks (End of Trial)
Change of serum creatinine
Time frame: 52 weeks (End of Trial)
Change of estimated glomerular filtration rate(eGFR)
Time frame: 52 weeks (End of Trial)
Change of 24-h urine microalbumin, microalbumin/creatinine ratio
Time frame: 52 weeks (End of Trial)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Primary Aldosteronism
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RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Hypertension, run by Third Military Medical 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 22 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of office systolic and diastolic pressure (time frame: 52 weeks (End of Trial)). 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 22 Mar 2024.