Clinical trial NCT05658705: Preoperative Supine Time for Adrenal Venous Sampling
Official title: Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Aldosteronism
Keywords: adrenal venous sampling
preoperative supine time
primary aldosteronism
resistant hypertension
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to understand whether the length of preoperative supine time would affect the AVS outcome.

Detailed description: Primary aldosteronism (PA) is the most common form of secondary hypertension, accounting for 5% of hypertensive patients and 17-23% in patients with resistant hypertension. Compared to the primary hypertension, PA is more prone to cause severe organ damage and even early death. Adrenal venous sampling (AVS) is an effective confirmatory test for subtyping unilateral and bilateral adrenal hyperplasia, helping doctors to make an accurate decision between surgery or medication. Supine in bed before AVS is recommended for a desirable result of AVS according to guidelines. However, investigating study about the most optimal preoperative supine time before AVS is lacking. This is a single-center prospective randomized controlled study. 120 patients diagnosed as PA and with willing for further AVS examination will be included. Participants will be randomly allocated to 15-min supine time group or 2-hours supine time group. The primary outcomes are the degrees of clinical and laboratory remission (blood pressure, type and dose of antihypertensive drugs, serum potassium, orthostatic ARR). The secondary outcomes are the technical success rate and adverse event of AVS (selective index≥2 is considered as successful surgery without corticotropin stimulate). Discussion: Primary aldosteronism is an intractable public health problem, and many techniques including AVS have been developed to correctly identify this disease. This study will help to understand whether the length of preoperative supine time would affect the diagnostic efficacy of AVS, and thus help to formulate a more reasonable AVS procedure.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of complete biochemical remission
timeFrame: At 6 months of follow-up
Secondary outcomes:
measure: The rate of complete clinical remission
timeFrame: At 6 months of follow-up
measure: Successful catheterization rate
timeFrame: At baseline
measure: Adverse events
timeFrame: At 3 months of follow-up
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Liu Zhen jie, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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citation: 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.
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.
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.