Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)
NCT Number: NCT06513676
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Primary Aldosteronism|Super Selective Adrenal Arterial Embolization
Sponsor: Xinjiang Medical University
Sex: ALL
Age: ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-15
Completion Date: 2028-08-01
Locations: The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 630000, China

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 the development of adrenal artery embolization as a new treatment for primary aldosteronism.

Primary Outcome Measures: Complete biochemical cure of PA, 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), 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)., 6 months post intervention
Secondary Outcome Measures: Changes in ambulatory blood pressure and baseline blood pressure, 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|Change of the number of antihypertensive medications, 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, 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, Readmission rate, defined as readmission for primary aldosteronism, 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), 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), 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), 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), 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), 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, 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, 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, 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), 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), 1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months