Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy (PA-SELECT)

April 14, 2025 updated by: Xiang Xie, Xinjiang Medical University

The First Affiliated Hospital of Xinjiang Medical University

The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease, which leads to increased sodium and potassium discharge, increased fluid volume and inhibition of renin-angiotensin-aldosterone system. It is one of the common causes of secondary hypertension as clinical symptoms with hypertension, hypokalemia, hyperaldosterone and low renin. It accounts for 5% to 13% of people with hypertension. In addition to the impact of hypertension itself on the body, the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events, and the risk of stroke, atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension, so early detection and reasonable treatment are crucial. PA can be divided into 6 types according to the etiology, of which the most common is idiopathic aldosteronism (IHA) and aldosteronoma, accounting for 60% and 30% respectively, unilateral adrenal hyperplasia followed, the other subtypes are less common. Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA, while unilateral PA is preferred by surgery and laparoscopic adrenalectomy. However, surgical treatment also has many limitations: First, not all patients with surgical indications have the opportunity to undergo adrenal resection. Surgical treatment is not suitable for patients with difficult laparoscopic operation, such as obesity, serious abdominal adhesion due to previous surgical history, and high-risk surgery, such as cardiovascular and cerebrovascular diseases and emphysema. In addition, adrenal resection may lead to adrenal dysfunction, serious infection, retroperitoneal hematoma and many other adverse reactions. The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved. The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria, and to conduct a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
570

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Xinjiang
      • Ürümqi, Xinjiang, China, 630000
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Age 18-60
  • Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
  • Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
  • Patients and their family members signed informed consent and agreed to participate in the study

Exclusion Criteria:

  • A history of severe hypersensitivity to contrast media
  • Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture 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, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
  • Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
  • Stroke, myocardial infarction and stent implantation occurred in the past 3 months
  • Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
  • Participated in other clinical trials within the past 3 months
  • Pregnant, breastfeeding, or planning a pregnancy
  • Identify patients with alcohol allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Superselective adrenal artery embolization group
Superselective adrenal artery embolization for primary aldosteronism
Procedure: Superselective adrenal artery embolization or adrenalectomy
Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
Other Names:
  • Adrenalectomy
Active Comparator: Adrenalectomy group
Adrenalectomy for primary aldosteronism
Procedure: Superselective adrenal artery embolization or adrenalectomy
Arm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
Other Names:
  • Adrenalectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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:

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)
6 months post intervention
Complete clinical cure of PA
Time Frame: 6 months post intervention
Complete clinical cure of PA, defined as normotension without antihypertensive medication
6 months post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of the number of antihypertensive medications
Time Frame: 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
Difference in the change of the number of antihypertensive medications
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
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)
Reported throughout the study period. Approximately 2 years
Readmission rate
Time Frame: Reported throughout the study period. Approximately 2 years
Readmission rate, defined as readmission for primary aldosteronism
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
Difference in the change of blood electrolytes (K+, Na + in mmol/L)
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
Difference in the change of plasma aldosterone (pg/mL)
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
Difference in the change of plasma cortisol (nmol/L)
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
Difference in the change of plasma renin (pg/ml)
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
Difference in the change of liver enzymes (ALT, AST in IU/L)
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
Difference in the change of serum creatinine in umol/L
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
Difference in the change of fasting blood glucose in mmol/L
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
Difference in the change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L
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
Difference in the change of 24-h urine microalbumin (mg/L)
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
Difference in the change of 24-h urine creatinine (umol/L)
1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months
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
24-hour ambulatory blood pressure and office systolic and diastolic pressure
1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinjiang Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First Affiliated Hospital of Xinjiang Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ying-Ying Zheng, PhD, 1st affiliatted hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20240613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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