The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 630000, China
Location status: Recruiting
Location contact
Changjiang Deng
CONTACT
Xiang xie
CONTACT
NCT Number: NCT06513676
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Ürümqi, Xinjiang, 630000, China
Location status: Recruiting
Changjiang Deng
CONTACT
Xiang xie
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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).
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
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
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)
Time frame: Reported throughout the study period. Approximately 2 years
Readmission rate, defined as readmission for primary aldosteronism
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)
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)
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)
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)
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)
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
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
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
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)
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)
Contact information is provided by the study sponsor or research team.
Xinjiang Medical University
Other
The First Affiliated Hospital of Xinjiang Medical University
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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