Primary AldosteronismNCT06513676
Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)
An observational study of Primary Aldosteronism and Super Selective Adrenal Arterial Embolization, run by Xinjiang Medical University at 1 site in China.
Trial summary
The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Aldosteronism, Super Selective Adrenal Arterial Embolization
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 1 Aug 2028
- Phase
- Observational
- 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
Study population: Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.
Who may be able to join
- Age 18-60 years old;
- Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
- Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
- The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;
Who cannot join
- A history of severe hypersensitivity to contrast media;
- There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal bleeding, etc;
- Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2);
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
- Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
- Cerebral apoplexy, myocardial infarction and stent implantation occurred in the past 3 months;
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- Serious other basic, such as heart dysfunction (grade IV), acute infection, autoimmune diseases, various malignant tumors and so on;
- Participated in other clinical trials within the past 3 months;
- Individual pregnancy, nursing or planning pregnancy;
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 First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 630000
Xiang xie, +869914366892, xiangxie999@sina.com
Changjiang Deng, +869914366892, 1187229853@qq.com
About this study
Official title: The First Affiliated Hospital of Xinjiang Medical University
The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.
Read the detailed description
As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Super selective adrenal artery embolization | SAAE for primary aldosteronism | |
| adrenectomy | Surgery to remove part of the adrenal gland | |
| Standard drug therapy | Drug treatment of primary aldosteronism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete biochemical cure of PA
Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both:
- Normalisation of serum potassium, and
- Normalisation of ARR, or
- Elevated ARR and i). Baseline PAC <190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Measured: 6 months post intervention
Complete clinical cure of PA
Complete clinical cure of PA, defined as normotension without antihypertensive medication
These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as <140/80 in the office, <135/85 at home or daytime ambulatory monitoring and <130/80 for 24h ambulatory blood pressure monitoring (24hABPM).
Measured: 6 months post intervention
Secondary outcomes (14)
Changes in ambulatory blood pressure and baseline blood pressure
24-hour ambulatory blood pressure and office systolic and diastolic pressure
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of the number of antihypertensive medications
Difference in the change of the number of antihypertensive medications
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Adverse events
Will be directly sought at each study visit through history and physical examination where appropriate Subjects will be encouraged to report between study visits and will have a mechanism to do so Will be classified by system, seriousness, causal relationship and expectedness according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Reported throughout the study period. Approximately 2 years
Readmission rate
Readmission rate, defined as readmission for primary aldosteronism
Measured: Reported throughout the study period. Approximately 2 years
Change of blood electrolytes (K+, Na +)
Difference in the change of blood electrolytes (K+, Na + in mmol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma aldosterone
Difference in the change of plasma aldosterone (pg/mL)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma cortisol
Difference in the change of plasma cortisol (nmol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma renin measured
Difference in the change of plasma renin (pg/ml)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of liver enzymes
Difference in the change of liver enzymes (ALT, AST in IU/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of kidney function
Difference in the change of serum creatinine in umol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of fasting blood glucose
Difference in the change of fasting blood glucose in mmol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of lipids profiles
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h urine microalbumin
Difference in the change of 24-h urine microalbumin (mg/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h 24-h urine creatinine
Difference in the change of 24-h urine creatinine (umol/L)
Measured: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Apr 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2028 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513676
- Sponsor's protocol ID
- 240528-09
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Xinjiang Medical University
- ClinicalTrials.gov ID
- NCT06513676
- Acronym / sponsor ID
- 240528-09
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 22 Jul 2024 (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 objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.
Detailed description
As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Super selective adrenal artery embolization | – | –SAAE for primary aldosteronism |
| adrenectomy | – | –Surgery to remove part of the adrenal gland |
| Standard drug therapy | – | –Drug treatment of primary aldosteronism |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Hypertensive patients were willing to participate and then hospitalized for further evaluation. Antihypertensive medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing. Hypertensive patients were prescribed with verapamil and/or terazosin based on Endocrine Society Clinical Practice Guideline. Patients with positive aldosterone-to-renin ratio underwent one of the following confirmatory tests: saline infusion test or captopril inhibition test. Adrenal CT scan and adrenal venous sampling (AVS) were performed for subtype classification of the PA. The PA patients were counseled on the various treatment options, including surgery, medications, and adrenal artery ablation.
Key inclusion criteria (4 listed)
- Age 18-60 years old;
- Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
- Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
- The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;
Key exclusion criteria (9 listed)
- A history of severe hypersensitivity to contrast media;
- There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal bleeding, etc;
- Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2);
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
- Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete biochemical cure of PA
Time frame: 6 months post intervention
Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both: 1. Normalisation of serum potassium, and 2. Normalisation of ARR, or 3. Elevated ARR and i). Baseline PAC <190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Complete clinical cure of PA
Time frame: 6 months post intervention
Complete clinical cure of PA, defined as normotension without antihypertensive medication These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as <140/80 in the office, <135/85 at home or daytime ambulatory monitoring and <130/80 for 24h ambulatory blood pressure monitoring (24hABPM).
14 secondary outcomes
Changes in ambulatory blood pressure and baseline blood pressure
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of the number of antihypertensive medications
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Adverse events
Time frame: Reported throughout the study period. Approximately 2 years
Readmission rate
Time frame: Reported throughout the study period. Approximately 2 years
Change of blood electrolytes (K+, Na +)
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma aldosterone
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma cortisol
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of plasma renin measured
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of liver enzymes
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of kidney function
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of fasting blood glucose
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of lipids profiles
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h urine microalbumin
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Change of 24-h 24-h urine creatinine
Time frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
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 23 Jul 2024.
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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.
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 Super Selective Adrenal Arterial Embolization, run by Xinjiang 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 9 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 23 Jul 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?
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 Xiang Xie (+869914366892, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete biochemical cure of PA (time frame: 6 months post intervention). 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 23 Jul 2024.