Primary AldosteronismNCT04409431
Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
A study testing Endovascular chemical Ablation of Adrenal Gland in people with Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure… Read more about this study
- Who is it for?
- Ages 30 to 60 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Dec 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- 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 grade 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.
- Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
- Allergy or any contraindications for the study drugs, contrast agents and alcohol.
- Refused to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third hospital affiliated to the Army Medical University
Chongqing, Chongqing Municipality, 400042
Li Yingsha, MD, 13594659454 ext. 68, yslimiss@163.com
Zhu Zhiming, MD
About this study
Official title: An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically. More than 60% of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors. At present, spironolactone is the most commonly used aldosterone receptor inhibitor. Long term use of spironolactone may cause hyperkalemia, hyperplasia of male mammary gland, hairiness of female and other adverse reactions. Therefore, the researchers suggest that partial removal of adrenals can reduce aldosterone level, lower blood pressure and restore potassium metabolism balance.
In patients with primary hyperaldosteronism, the level of aldosterone increases, which can cause vascular endothelial dysfunction, myocardial injury and ventricular fibrosis. The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure. Adrenal artery ablation can reduce aldosterone level, but the long-term effect on cardiovascular system is unknown. In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system, the researchers conducted an open cohort study on patients with primary aldosteronism (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). To observe the effect of adrenal artery ablation and spironolactone on blood pressure, blood electrolyte, metabolic index, cardiovascular events and cardiovascular death risk in patients with primary aldosteronism, and to explore its efficacy and safety.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- Endovascular chemical Ablation of Adrenal Gland
- Keywords
- Primary Aldosteronism, Hypertension, Adrenal Artery Ablation, Spironolactone
- 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 partial ablation of adrenal gland by endovascular injection of dehydrated alcohol
| Study group | Role | What they receive |
|---|---|---|
| Adrenal Artery Ablation | Experimental | Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Receives: Procedure: Endovascular chemical Ablation of Adrenal Gland |
| Spironolactone | No intervention | Patients in this group will be treated with aldosterone 20-80mg daily according to blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of office systolic and diastolic pressure compared with the baseline between two groups
Change of office systolic and diastolic pressure compared with the baseline between the intervention and control group at the end of the study
Measured: 3 years(End of Trial)
Incidence of major adverse cardiac events (MACE)(%) between two groups
Incidence of major adverse cardiac events (MACE)(%)（cardiac death, myocardial infarction and target vessel revascularisation） between two groups at the end of the study
Measured: 3 years(End of Trial)
Secondary outcomes (4)
Change of 24-h average systolic blood pressure between two groups
Change of 24-h average systolic blood pressure between two groups at end of the study
Measured: 3 years(End of Trial)
Change of 24-h average diastolic blood pressure between two groups
Change of 24-h average diastolic blood pressure between two groups at end of the study
Measured: 3 years(End of Trial)
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups at end of the study
Measured: 3 years(End of Trial)
Change of carotid intima-media thickness assessed by carotid ultrasound between two groups
Change of carotid intima-media thickness assessed by carotid ultrasound between two groups at end of the study
Measured: 3 years(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 posted1 Jun 2020
- Study start1 Dec 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion1 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with spironolactone
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- Investigators
- Zhu ZM, MD, Study director, The third militery medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409431
- Sponsor's protocol ID
- AAA-S
- Status last verified
- Aug 2024
- First submitted
- 10 Feb 2020
- Last updated
- 20 Aug 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Cohort Study on Effects and Long-term Prognosis of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT04409431
- Acronym / sponsor ID
- AAA-S
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- Primary Aldosteronism, Hypertension, Adrenal Artery Ablation, Spironolactone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Jun 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 one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically. More than 60% of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors. At present, spironolactone is the most commonly used aldosterone receptor inhibitor. Long term use of spironolactone may cause hyperkalemia, hyperplasia of male mammary gland, hairiness of female and other adverse reactions. Therefore, the researchers suggest that partial removal of adrenals can reduce aldosterone level, lower blood pressure and restore potassium metabolism balance.
In patients with primary hyperaldosteronism, the level of aldosterone increases, which can cause vascular endothelial dysfunction, myocardial injury and ventricular fibrosis. The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure. Adrenal artery ablation can reduce aldosterone level, but the long-term effect on cardiovascular system is unknown. In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system, the researchers conducted an open cohort study on patients with primary aldosteronism (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). To observe the effect of adrenal artery ablation and spironolactone on blood pressure, blood electrolyte, metabolic index, cardiovascular events and cardiovascular death risk in patients with primary aldosteronism, and to explore its efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. Patients in the Control group will be treated with spironolactone
| Arm | Type | Receives |
|---|---|---|
| Adrenal Artery Ablation | Experimental | Procedure: Endovascular chemical Ablation of Adrenal GlandPatients in the Intervention group will be treated with endovascular chemical ablation of adrenal gland by endovascular injection of dehydrated alcohol. |
| Spironolactone | No intervention | –Patients in this group will be treated with aldosterone 20-80mg daily according to blood pressure |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- Signed informed consent and agreed to participate in this study.
Key exclusion criteria (14 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 partial 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 compared with the baseline between two groups
Time frame: 3 years(End of Trial)
Change of office systolic and diastolic pressure compared with the baseline between the intervention and control group at the end of the study
Incidence of major adverse cardiac events (MACE)(%) between two groups
Time frame: 3 years(End of Trial)
Incidence of major adverse cardiac events (MACE)(%)（cardiac death, myocardial infarction and target vessel revascularisation） between two groups at the end of the study
4 secondary outcomes
Change of 24-h average systolic blood pressure between two groups
Time frame: 3 years(End of Trial)
Change of 24-h average diastolic blood pressure between two groups
Time frame: 3 years(End of Trial)
Change of parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) between two groups
Time frame: 3 years(End of Trial)
Change of carotid intima-media thickness assessed by carotid ultrasound between two groups
Time frame: 3 years(End of Trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Zhu ZM, MD study director
The third militery medical 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 Endovascular chemical Ablation of Adrenal Gland in people with 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yingsha, MD (13594659454 ext. 68, yslimiss@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of office systolic and diastolic pressure compared with the baseline between two groups (time frame: 3 years(End of Trial)). The study lists 2 primary outcomes in all. 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 20 Aug 2024.