The Comparison of Single Catheter and Double Catheter Adrenal Vein Sampling Methods Based on the Upper Limb Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single catheter adrenal vein sampling, Double catheters adrenal vein sampling.
- Who it may be relevant to
- Registry conditions: Primary Aldosteronism. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Studies have shown that the prevalence of PA in an unselected hypertensive population ranges from 5% to 11% , while the prevalence in patients with resistant hypertension is approximately 20% . PA is one of the most common causes of secondary hypertension , and its prevalence increases with rising blood pressure levels. Due to the adverse effects of PA on the heart, arterial walls, and kidneys, it contributes to the occurrence of cardiovascular events, with atrial fibrillation being the most common . In summary, PA is characterized by rapid onset, significant symptoms, obscurity, and severe complications, making early diagnosis and targeted treatment essential for prevention. This study aims to explore a quasi-selected prospective randomized controlled method to compare the clinical efficacy differences between single-catheter and dual-catheter adrenal sampling via the right upper limb approach. The study seeks to clarify the effectiveness and safety of single-catheter sampling from the upper limb, providing a more efficient and cost-effective solution for the subtype diagnosis of patients with Primary Aldosteronism (PA).
Interventions
- Procedure Single catheter adrenal vein sampling
The clinical invasive procedure involves inserting a single catheter into the right and left adrenal veins to collect blood samples from both adrenal veins. - Procedure Double catheters adrenal vein sampling
The clinical invasive procedure involves inserting double catheters into the right and left adrenal veins to collect blood samples from both adrenal veins.
Primary outcome measures
- Success rate of left-sided adrenal vein sampling between two groups [Time frame: 7 month(End of Trial)]
Secondary outcome measures (4)
- Change of material costs between two groups [Time frame: 7 month(End of Trial)]
- Change of average operation time of left-side adrenal vein sampling between two groups [Time frame: 7 month(End of Trial)]
- Change of average fluoroscopy time of adrenal vein sampling between two groups [Time frame: 7 month(End of Trial)]
- Change of the surgical supplies cost between two groups [Time frame: 7 month(End of Trial)]
Eligibility criteria
Inclusion criteria
- Patients aged 18-70 years with hypertension.
- Initial screening shows a standing aldosterone/renin ratio (ARR) > 3.7, a baseline aldosterone level > 10 ng/dl, aldosterone level > 6 ng/dl after a saline load test, or aldosterone decrease of less than 30% after a captopril suppression test, consistent with a diagnosis of primary aldosteronism.
- Voluntary participation in the trial, with signed informed consent.
Exclusion criteria
- Patients with an allergy to iodinated contrast agents.
- Patients who are pregnant, breastfeeding, or planning to become pregnant.
- Patients with severe comorbidities, such as renal failure, liver cirrhosis, metastatic tumors, or those who have had an acute stroke or acute myocardial infarction, as well as patients with a history of surgery within the past month.
- Patients suspected of having adrenal cortical carcinoma.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06737848 · AMCIIT241106