Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorXinjiang Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Superselective adrenal artery embolization or adrenalectomy
Procedure/SurgeryArm A underwent SAAE treatment, and arm B underwent laparoscopic adrenalectomy.
Treatment groups
570 Participants
are divided into 2 treatment groupsGroup A: Superselective adrenal artery embolization groupExperimental treatment 1 intervention
Group B: Adrenalectomy groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
6 months post intervention2
Complete clinical cure of PA
Complete clinical cure of PA, defined as normotension without antihypertensive medication
Time frame
6 months post interventionSecondary outcomes
1
Changes in ambulatory blood pressure and baseline blood pressure
24-hour ambulatory blood pressure and office systolic and diastolic pressure
Time frame
1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months2
Change of the number of antihypertensive medications
Difference in the change of the number of antihypertensive medications
Time frame
1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months3
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)
Time frame
Reported throughout the study period. Approximately 2 years4
Readmission rate
Readmission rate, defined as readmission for primary aldosteronism
Time frame
Reported throughout the study period. Approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xinjiang Medical University
Lead sponsor
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Source ClinicalTrials.gov