- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658705
Preoperative Supine Time for Adrenal Venous Sampling (PSTAVS)
April 24, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liu Zhen jie, MD,PhD
- Phone Number: 86-0571-87913706
- Email: lawson4001@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Zhejie Liu, MD,PhD
- Phone Number: 86 15268135830
- Email: lawson3001@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group(15-min supine group)
Participants in the experimental group will keep supine position for 15 minutes before AVS.
|
The length of preoperative supine time before AVS was 15 minutes.
|
Active Comparator: control group(2-hour supine group)
Participants in the control group will keep supine position for 2 hours before AVS.
|
The length of preoperative supine time before AVS was 2 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of complete biochemical remission
Time Frame: At 6 months of follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of complete clinical remission
Time Frame: At 6 months of follow-up
|
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
|
Successful catheterization rate
Time Frame: At baseline
|
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
|
Adverse events
Time Frame: At 3 months of follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Liu Zhen jie, MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2023
Primary Completion (Estimated)
March 29, 2025
Study Completion (Estimated)
March 29, 2025
Study Registration Dates
First Submitted
November 28, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAHZhejiangU-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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