Primary Aldosteronism Clinical Trial
— PSTAVSOfficial title:
Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial
This study aim to understand whether the length of preoperative supine time would affect the AVS outcome.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 29, 2025 |
Est. primary completion date | March 29, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients are clinically diagnosed as primary aldosteronism with ARR=37 (PAC showed as pg/ml, renin showed as µIU/mL) and passed through PA confirmatory tests (PAC-post CCT>110pg/ml, PAC-post SSIT >80pg/ml, or PAC-post FST>60pg/ml). PAC: plasma aldosterone concentration; 2. Patients with willing for AVS; 3. Age 18 or above, male or female, with legal capacity. Exclusion Criteria: 1. Patients with suspected adrenocortical carcinoma or pheochromocytoma; 2. Patients with high risk of adrenal surgery; 3. Patients have been subtyping to glucocorticoid-suppressible hyperaldosteronism or familial hyperaldosteronism type III; 4. Patients were diagnosed as Cushing syndrome or subclinical Cushing syndrome; 5. Patients were treated with glucocorticoids recently; 6. Patients with whole body or venipuncture area infection; 7. Patients with venous access thrombosis; 8. Patients are allergic to iodine; 9. Patients with X-ray contraindications; 10. Patients with coagulation dysfunction; 11. Patients are unable to cooperate and follow-up. |
Country | Name | City | State |
---|---|---|---|
China | The second affiliated hospital of zhejiang university school of medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. — View Citation
Liu Z, He M, Song X, Xu F, Zhang B, Chen B, Yu P, Zhou H, Shan L, Wang H, Gu Z, Zhong S, Xu X, Tao Z, Chen B, Gu W. Computed tomography image fusion, Coaxial guidewire technique, Fast intraprocedural cortisol testing technique improves success rate and decreases radiation exposure, procedure time, and contrast use for adrenal vein sampling. J Hypertens. 2021 Sep 1;39(9):1918-1925. doi: 10.1097/HJH.0000000000002852. — View Citation
Rossi GP, Auchus RJ, Brown M, Lenders JW, Naruse M, Plouin PF, Satoh F, Young WF Jr. An expert consensus statement on use of adrenal vein sampling for the subtyping of primary aldosteronism. Hypertension. 2014 Jan;63(1):151-60. doi: 10.1161/HYPERTENSIONAHA.113.02097. Epub 2013 Nov 11. — View Citation
Seccia TM, Miotto D, Battistel M, Motta R, Barisa M, Maniero C, Pessina AC, Rossi GP. A stress reaction affects assessment of selectivity of adrenal venous sampling and of lateralization of aldosterone excess in primary aldosteronism. Eur J Endocrinol. 2012 May;166(5):869-75. doi: 10.1530/EJE-11-0972. Epub 2012 Feb 13. — View Citation
Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052. — View Citation
Zennaro MC, Boulkroun S, Fernandes-Rosa FL. Pathogenesis and treatment of primary aldosteronism. Nat Rev Endocrinol. 2020 Oct;16(10):578-589. doi: 10.1038/s41574-020-0382-4. Epub 2020 Jul 28. — View Citation
Zhong S, Zhang T, He M, Yu H, Liu Z, Li Z, Song X, Xu X. Recent Advances in the Clinical Application of Adrenal Vein Sampling. Front Endocrinol (Lausanne). 2022 Feb 9;13:797021. doi: 10.3389/fendo.2022.797021. eCollection 2022. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of complete biochemical remission | Compare the rate of complete biochemical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium. According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes. The proportion of complete biochemical remission according to PASO consensus criteria. | At 6 months of follow-up | |
Secondary | The rate of complete clinical remission | Compare the rate of complete clinical remission between two groups. The proportion of complete clinical remission according to PASO consensus criteria. Clinical outcomes were determined by the blood pressure response to treatment and the number and dosage of antihypertensive medications. | At 6 months of follow-up | |
Secondary | Successful catheterization rate | Intraoperative bilateral SI value was used to judge whether the blood collection cannula was successful. In the surgery absence of osyntropin, SI=2 was used as the standard for successful blood collection and LI=2 was used for judging the dominant side aldosterone secretion. | At baseline | |
Secondary | Adverse events | Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism, ect. | At 3 months of follow-up |
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