The Comparison of Single Catheter and Double Catheter Adrenal Vein Sampling Methods Based on the Upper Limb Approach

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Procedure: Single catheter adrenal vein sampling; Procedure: Double catheters adrenal vein sampling

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Li,MD; Phone Number: 13372683559; Email: doublepear@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Catheter Adrenal Vein Sampling; Patients in the Intervention group will utilize a multifunctional catheter for bilateral adrenal vein sampling.	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.
Active Comparator: Double Catheter Adrenal Vein Sampling; Patients in this group will utilize two catheters for bilateral adrenal vein sampling.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of left-sided adrenal vein sampling between two groups	Biochemical analysis of puncture-point blood samples: A selection index (SI) ≥ 2, defined as the ratio of adrenal plasma cortisol concentration (PCC) to peripheral PCC, indicates successful unilateral aldosterone venous sampling (AVS).	7 month(End of Trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of material costs between two groups		7 month(End of Trial)
Change of average operation time of left-side adrenal vein sampling between two groups	The surgical doctor will record the operation time for adrenal vein sampling from the left adrenal vein and compare change of the average operation time between the two groups at end of the study.	7 month(End of Trial)
Change of average fluoroscopy time of adrenal vein sampling between two groups	Change of average fluoroscopy time of adrenal vein sampling between two groups at the end of the study.	7 month(End of Trial)
Change of the surgical supplies cost between two groups	Change of the surgical supplies cost between two groups at the end of the study.	7 month(End of Trial)

Collaborators and Investigators

• Sponsor: Army Medical University, China
• Investigators: Study Director: Li Li, MD, Army Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: AMCIIT241106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No