Comparing two methods for adrenal venous sampling in patients with hyperaldosteronism
Antecubital Versus Femoral Approach for Adrenal Venous Sampling: A Randomised Controlled Trial
This study is testing whether a new way to collect blood samples from the arm is better and safer than the traditional method from the leg for people with high aldosterone levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06029803 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the success rate and safety of adrenal venous sampling (AVS) using an antecubital approach versus the traditional femoral approach in patients diagnosed with primary aldosteronism. Participants aged 18 to 60 with confirmed primary aldosteronism will be randomly assigned to one of the two groups. The study will record clinical, laboratory, and examination data to evaluate the effectiveness and safety of each method. The antecubital approach has previously shown a higher success rate and lower complication incidence, making this comparison significant for improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with confirmed primary aldosteronism.
Not a fit: Patients with severe comorbidities, those who refuse adrenalectomy, or those with certain contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and safer method for diagnosing primary aldosteronism, improving treatment strategies for patients.
How similar studies have performed: Previous studies have indicated that the antecubital approach may achieve a higher success rate than the femoral approach, suggesting potential for success in this novel comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged from 18 to 60 with no limits in sex; 2. Patients with confirmed primary aldosteronism; 3. Patients or their legal representatives sign written informed consent approved by the ethics committee Exclusion Criteria: 1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months； 2. An estimated glomerular filtration rate \<45 ml/min/1.73 m2, or serum creatinine \>176 μmol/L； 3. Patients who refuse adrenalectomy; 4. suspected of having an adrenocortical carcinoma; 5. allergy to contrast agent; 6. pregnant, nursing, or planning to become pregnant
Where this trial is running
Beijing, Beijing
- Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Hui Dong, MD — Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study coordinator: Hui Dong, MD
- Email: donghui666@sina.com
- Phone: 86-010-88322387
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.