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

NCT06737848 | Not Yet Recruiting

• 1 other identifier: AMCIIT241106
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  7 month(End of Trial)

• Change of average fluoroscopy time of adrenal vein sampling between two groups

  7 month(End of Trial)

• Change of the surgical supplies cost between two groups

  7 month(End of Trial)

Study Arms (2)

Single Catheter Adrenal Vein Sampling

EXPERIMENTAL

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

Procedure: Single catheter adrenal vein sampling

Double Catheter Adrenal Vein Sampling

ACTIVE COMPARATOR

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

Procedure: Double catheters adrenal vein sampling

Interventions

Single catheter adrenal vein sampling 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.

Single Catheter Adrenal Vein Sampling

Double catheters adrenal vein sampling PROCEDURE

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

Double Catheter Adrenal Vein Sampling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Army Medical University, China: lead

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Li Li, MD

  Army Medical University, China

  STUDY DIRECTOR

Central Study Contacts

Li Li,MD

CONTACT

13372683559; doublepear@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 17, 2024
• Study Start: December 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 31, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share