Effect of Supine Time on Adrenal Venous Sampling Outcomes
Preoperative Supine Time for Adrenal Venous Sampling: A Prospective Randomized Controlled Trial
This study is testing whether lying down for 15 minutes or 2 hours before a specific test can improve results for people with primary aldosteronism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05658705 on ClinicalTrials.gov |
What this trial studies
This study investigates how the duration of preoperative supine time influences the outcomes of adrenal venous sampling (AVS) in patients diagnosed with primary aldosteronism. It is a single-center, prospective randomized controlled trial involving 120 participants who will be assigned to either a 15-minute or a 2-hour supine time before undergoing AVS. The primary outcomes include clinical and laboratory remission rates, while secondary outcomes focus on the technical success rate and any adverse events related to AVS. The findings aim to optimize preoperative protocols for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and above who have been clinically diagnosed with primary aldosteronism and are willing to undergo adrenal venous sampling.
Not a fit: Patients with suspected adrenal tumors, high surgical risk, or other specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved AVS outcomes and better management of primary aldosteronism, potentially reducing complications associated with resistant hypertension.
How similar studies have performed: While adrenal venous sampling is a well-established procedure, this specific investigation into the optimal preoperative supine time is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The second affiliated hospital of zhejiang university school of medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Liu Zhen jie, MD,PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Liu Zhen jie, MD,PhD
- Email: lawson4001@zju.edu.cn
- Phone: 86-0571-87913706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.