Primary AldosteronismPhase 3NCT03653845
Adrenal Artery Ablation for Primary Aldosteronism
A Phase 3 study testing Endovascular chemical Ablation of Adrenal Gland and Sequenced antihypertensvie drugs with titrated dosage in people with Primary Aldosteronism and Hypertension, run by Third Military Medical University at 2 sites in China.
Trial summary
Primary aldosteronism (PA) is one of the most common causes 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… 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 and Sequenced antihypertensvie drugs with titrated dosage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2018to 1 Jan 2020
- Phase
- Phase 3
- 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 were 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 3 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
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Hongbo He, MD., 86-23-68757880, cqhehongbo@gmail.com
Zhiming Zhu, MD.
- Recruiting
The third hospital affiliated to the Third Military Medical University
Chongqing, 400042
Zhiming Zhu, MD, PhD, 86-023-68705094, zhuzm@yahoo.com
Zhiming Zhu, MD, PhD
About this study
Official title: Adrenal Artery Ablation for Primary Aldosteronism：A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Primary Aldosteronism
Primary aldosteronism (PA) is one of the most common causes 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.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- Endovascular chemical Ablation of Adrenal Gland, Sequenced antihypertensvie drugs with titrated dosage
- Keywords
- Hypertension, Primary Aldosteronism, Ablation, Adrenal Gland
- 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.
Sequenced antihypertensvie drugs with titrated dosageDrug
Patients will be treated with different antihypertensive drugs in two groups.
| Study group | Role | What they receive |
|---|---|---|
| Intevention | Experimental | Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg. Receives: Procedure: Endovascular chemical Ablation of Adrenal Gland; Drug: Sequenced antihypertensvie drugs with titrated dosage |
| Control | Active comparator | Patients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg. Receives: Drug: Sequenced antihypertensvie drugs with titrated dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
Difference in the change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Secondary outcomes (15)
Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial
Difference in the change of blood electrolytes（serum potassium and natrium in mmol/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone measured at baseline and the end of the trial
Difference in the change of plasma aldosterone and 24-h urine aldosterone compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of plasma renin measured at baseline and the end of the trial
Difference in the change of plasma renin compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of 24-h average systolic blood pressure measured at the end of the trial compared with the baseline
Change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) in the intervention group.
Measured: 24 weeks
Change of anti-hypertensive regimen assessed at baseline and the end of the trial
Difference in the change of anti-hypertensive regimen compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
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 measured at baseline and the end of the trial
Difference in the 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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of home systolic and diastolic pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Difference in the change of office systolic and diastolic pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of liver enzymes measured at baseline and the end of the trial
Difference in the change of liver enzymes (ALT, AST in IU/L) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of kidney function measured at baseline and the end of the trial
Difference in the change of serum creatinine in umol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of fasting blood glucose and lipids profiles measured at baseline and the end of the trial
Difference in the change of fasting blood glucose and lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of sex hormones measured at baseline and the end of the trial
Difference in the change of 17-OH, DHEAS, testosterone and estrogen levels compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial
Difference in the change of 24-h urine microalbumin, microalbumin/creatinine ratio compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) measured at baseline and the end of the trial
Difference in the change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, in millimetre(mm), and LVEF(%), LVM in gram) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
Difference in the change of carotid intima-media thickness(CIMT) in millimetre(mm) compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jan 2020 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653845
- Sponsor's protocol ID
- AAA-PA
- Status last verified
- Aug 2018
- First submitted
- 7 Jun 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Artery Ablation for Primary Aldosteronism：A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT03653845
- Acronym / sponsor ID
- AAA-PA
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- Hypertension, Primary Aldosteronism, Ablation, Adrenal Gland
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 31 Aug 2018 (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 causes 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.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intevention | Experimental | Procedure: Endovascular chemical Ablation of Adrenal Gland, Drug: Sequenced antihypertensvie drugs with titrated dosagePatients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg. |
| Control | Active comparator | Drug: Sequenced antihypertensvie drugs with titrated dosagePatients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg. |
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 were 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 | Intevention |
| Sequenced antihypertensvie drugs with titrated dosagePatients will be treated with different antihypertensive drugs in two groups. | Drug | Control, Intevention |
Primary outcome
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Difference in the change of 24-h average systolic blood pressure compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
15 secondary outcomes
Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial
Time frame: 24 weeks
Change of plasma aldosterone and 24-h urine aldosterone measured at baseline and the end of the trial
Time frame: 24 weeks
Change of plasma renin measured at baseline and the end of the trial
Time frame: 24 weeks
Change of 24-h average systolic blood pressure measured at the end of the trial compared with the baseline
Time frame: 24 weeks
Change of anti-hypertensive regimen assessed at baseline and the end of the trial
Time frame: 24 weeks
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 measured at baseline and the end of the trial
Time frame: 24 weeks
Change of home systolic and diastolic pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Change of office systolic and diastolic pressure measured at baseline and the end of the trial
Time frame: 24 weeks
Change of liver enzymes measured at baseline and the end of the trial
Time frame: 24 weeks
Change of kidney function measured at baseline and the end of the trial
Time frame: 24 weeks
Change of fasting blood glucose and lipids profiles measured at baseline and the end of the trial
Time frame: 24 weeks
Change of sex hormones measured at baseline and the end of the trial
Time frame: 24 weeks
Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial
Time frame: 24 weeks
Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) measured at baseline and the end of the trial
Time frame: 24 weeks
Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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 third hospital affiliated to the Third Military Medical University
Chongqing, China
The third hospital affiliated to the Third Military Medical University
Chongqing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endovascular chemical Ablation of Adrenal Gland and Sequenced antihypertensvie drugs with titrated dosage in people with Primary Aldosteronism and Hypertension, run by Third Military Medical University at 2 sites 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial (time frame: 24 weeks). 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 31 Aug 2018.