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

Army Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Primary Aldosteronism

Treatments: Procedure: Double catheters adrenal vein sampling; Procedure: Single catheter adrenal vein sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT06737848

AMCIIT241106

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Single Catheter Adrenal Vein Sampling

Experimental group

Description:

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

Treatment:

Procedure: Single catheter adrenal vein sampling

Double Catheter Adrenal Vein Sampling

Active Comparator group

Description:

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

Treatment:

Procedure: Double catheters adrenal vein sampling