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

NCT ID: NCT06737848

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-30
• Study Completion Date: 2025-07-31

Brief Summary

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).

Conditions

Primary Aldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Catheter Adrenal Vein Sampling

Patients in the Intervention group will utilize a multifunctional catheter for bilateral adrenal vein sampling.

Group Type: EXPERIMENTAL

Single catheter adrenal vein sampling

Intervention Type: PROCEDURE

The clinical invasive procedure involves inserting a single catheter into the right and left adrenal veins to collect blood samples from both adrenal veins.

Double Catheter Adrenal Vein Sampling

Patients in this group will utilize two catheters for bilateral adrenal vein sampling.

Group Type: ACTIVE_COMPARATOR

Double catheters adrenal vein sampling

Intervention Type: PROCEDURE

The clinical invasive procedure involves inserting double catheters into the right and left adrenal veins to collect blood samples from both adrenal veins.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Army Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Li Li

Deputy Director of the department of Hypertension & Endocrinology, Daping Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Li, MD

Role: STUDY_DIRECTOR

Army Medical University, China

Central Contacts

Li Li,MD

Role: CONTACT

Phone: 13372683559

Email: doublepear@tmmu.edu.cn

Other Identifiers

AMCIIT241106

Identifier Type: -

Identifier Source: org_study_id