Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorXinjiang Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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medications that affect the renin-angiotensin-aldosterone system were stopped for two weeks, diuretics and MRA were withdrawn for at least 4 weeks before ARR testing.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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 3 trial groupsGroup A: Super selective adrenal artery embolization
Group B: adrenectomy
Group C: Standard drug therapy
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: 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)
Time frame
6 months post intervention2
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).
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
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Source ClinicalTrials.gov