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Preoperative Supine Time for Adrenal Venous Sampling (PSTAVS)

Primary Purpose

Primary Aldosteronism

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
15-min supine time
2-hour supine time
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism focused on measuring adrenal venous sampling, preoperative supine time, primary aldosteronism, resistant hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • The second affiliated hospital of zhejiang university school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group(15-min supine group)

control group(2-hour supine group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 28, 2022
Last Updated
September 7, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05658705
Brief Title
Preoperative Supine Time for Adrenal Venous Sampling
Acronym
PSTAVS
Official Title
Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
March 29, 2025 (Anticipated)
Study Completion Date
March 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
adrenal venous sampling, preoperative supine time, primary aldosteronism, resistant hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group(15-min supine group)
Arm Type
Experimental
Arm Description
Participants in the experimental group will keep supine position for 15 minutes before AVS.
Arm Title
control group(2-hour supine group)
Arm Type
Active Comparator
Arm Description
Participants in the control group will keep supine position for 2 hours before AVS.
Intervention Type
Procedure
Intervention Name(s)
15-min supine time
Intervention Description
The length of preoperative supine time before AVS was 15 minutes.
Intervention Type
Procedure
Intervention Name(s)
2-hour supine time
Intervention Description
The length of preoperative supine time before AVS was 2 hours.
Primary Outcome Measure Information:
Title
The rate of complete biochemical remission
Description
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.
Time Frame
At 6 months of follow-up
Secondary Outcome Measure Information:
Title
The rate of complete clinical remission
Description
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.
Time Frame
At 6 months of follow-up
Title
Successful catheterization rate
Description
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.
Time Frame
At baseline
Title
Adverse events
Description
Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism, ect.
Time Frame
At 3 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Zhen jie, MD,PhD
Phone
86-0571-87913706
Email
lawson4001@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Zhen jie, MD,PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affiliated hospital of zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhejie Liu, MD,PhD
Phone
15268135830
Ext
86
Email
lawson3001@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32327102
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.
Results Reference
background
PubMed Identifier
35222268
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.
Results Reference
background
PubMed Identifier
34039913
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.
Results Reference
background
PubMed Identifier
32724183
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.
Results Reference
background
PubMed Identifier
26934393
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.
Results Reference
background
PubMed Identifier
24218436
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.
Results Reference
background
PubMed Identifier
22330150
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.
Results Reference
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Preoperative Supine Time for Adrenal Venous Sampling

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