Preoperative Supine Time for Adrenal Venous Sampling

NCT05658705 | Recruiting

• 1 other identifier: SAHZhejiangU-004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

adrenal venous sampling; preoperative supine time; primary aldosteronism; resistant hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The rate of complete clinical remission

  At 6 months of follow-up

• Successful catheterization rate

  At baseline

• Adverse events

  At 3 months of follow-up

Study Arms (2)

experimental group(15-min supine group)

EXPERIMENTAL

Participants in the experimental group will keep supine position for 15 minutes before AVS.

Procedure: 15-min supine time

control group(2-hour supine group)

ACTIVE COMPARATOR

Participants in the control group will keep supine position for 2 hours before AVS.

Procedure: 2-hour supine time

Interventions

15-min supine time PROCEDURE

The length of preoperative supine time before AVS was 15 minutes.

experimental group(15-min supine group)

2-hour supine time PROCEDURE

The length of preoperative supine time before AVS was 2 hours.

control group(2-hour supine group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients with willing for AVS;
• Age 18 or above, male or female, with legal capacity.

You may not qualify if:

• Patients with suspected adrenocortical carcinoma or pheochromocytoma;
• Patients with high risk of adrenal surgery;
• Patients have been subtyping to glucocorticoid-suppressible hyperaldosteronism or familial hyperaldosteronism type III;
• Patients were diagnosed as Cushing syndrome or subclinical Cushing syndrome;
• Patients were treated with glucocorticoids recently;
• Patients with whole body or venipuncture area infection;
• Patients with venous access thrombosis;
• Patients are allergic to iodine;
• Patients with X-ray contraindications;
• Patients with coagulation dysfunction;
• Patients are unable to cooperate and follow-up.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 32327102 BACKGROUND

• 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.

  PMID: 35222268 BACKGROUND

• 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.

  PMID: 34039913 BACKGROUND

• 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.

  PMID: 32724183 BACKGROUND

• 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.

  PMID: 26934393 BACKGROUND

• 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.

  PMID: 24218436 BACKGROUND

• 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.

  PMID: 22330150 BACKGROUND

• He M, Zhang Y, Song X, Zhang T, Yu H, Ji Y, Gong S, Chai P, Chen J, Wang S, Chen B, Xu X, Liu Z. Preoperative supine time for adrenal venous sampling: a prospective randomized controlled trial. Trials. 2024 Jan 2;25(1):14. doi: 10.1186/s13063-023-07872-2.

  PMID: 38167540 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Liu Zhen jie, MD,PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Zhen jie, MD,PhD

CONTACT

86-0571-87913706; lawson4001@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients and investigators cannot be blinded due to the type of study. To minimize the potential influence of this limitation, we will assign the most professional vascular doctor to perform the same operation on the two groups of patients, and statisticians will be blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 21, 2022
• Study Start: March 29, 2023
• Primary Completion: March 29, 2025
• Study Completion: March 29, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)