NCT06192238

Brief Summary

This multicenter study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of adrenal venous sampling (AVS) via antecubital and femoral approach for patients with primary aldosteronism. The consistency of AVS with pathological results and clinical outcomes, the factors affecting the success of AVS, and the optimal population for AVS will be aslo analyzed in this study.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

48 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

December 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

December 21, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

Adrenal venous samplingHyperaldosteronismAntecubital approachFemoral approachPathological results

Outcome Measures

Primary Outcomes (1)

  • The success rate of bilateral adrenal venous sampling

    Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation)

    At AVS procedure

Secondary Outcomes (9)

  • The success rate of left adrenal venous sampling

    At AVS procedure

  • The success rate of right adrenal venous sampling

    At AVS procedure

  • Selection of intraoperative catheter

    At AVS procedure

  • Time of the procedure

    At AVS procedure

  • Time of fluoroscopy

    At AVS procedure

  • +4 more secondary outcomes

Study Arms (1)

Adrenal Venous Sampling

Patients with Primary Aldosteronism (PA) undergoing Adrenal Venous Sampling via antecubital approach or femoral approach to discriminate PA forms with unilateral from bilateral excess aldosterone production.

Procedure: adrenal venous sampling

Interventions

Patients with Primary Aldosteronism (PA) undergoing Adrenal Venous Sampling via antecubital approach or femoral approach to discriminate PA forms with unilateral from bilateral excess aldosterone production.

Adrenal Venous Sampling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed primary aldosteronism aged from 18 to 65 with no limits in sex

You may qualify if:

  • Aged from 18 to 65 with no limits in sex;
  • Patients with confirmed primary aldosteronism;
  • Patients or their legal representatives sign written informed consent approved by the ethics committee;

You may not qualify if:

  • Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months;
  • An estimated glomerular filtration rate \<45 ml/min/1.73 m2, or serum creatinine \>176 μmol/L;
  • Patients who refuse adrenalectomy;
  • Suspected of having an adrenocortical carcinoma;
  • Allergy to contrast agent;
  • Pregnant, nursing, or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Chuiyangliu Hospital affiliated to Tsinghua University

Beijing, Beijing Municipality, 100022, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101100, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401147, China

Location

People's Hospital Affiliated to ChongqingThree Gorges Medical college

Chongqing, Chongqing Municipality, 404100, China

Location

Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361016, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730000, China

Location

The Forth People's Hosptal of Nanhai District of Foshan City

Foshan, Guangdong, 528211, China

Location

Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)

Guangzhou, Guangdong, 510080, China

Location

Shenzhen Third People's Hospital,Shenzhen, Guangdong Province 518112, China

Shenzhen, Guangdong, 518112, China

Location

Shenzhen Dapeng New District Kuiyong People's Hospital

Shenzhen, Guangdong, 518116, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530000, China

Location

Nanning Third People's Hospital

Nanning, Guangxi, 547000, China

Location

The Second Affiliated Hospital Of Guizhou Medical University

Kaili, Guizhou, 556000, China

Location

Tangshan hongci Hospital

Tangshan, Hebei, 063000, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 450000, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450007, China

Location

Zhengzhou Yihe Hospital

Zhengzhou, Henan, 450018, China

Location

Zhoukou Central Hospital

Zhoukou, Henan, 466000, China

Location

Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Xiangyang, Hubei, 441021, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 443000, China

Location

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Jiangxi Provincial People's Hospital (The First Affiliated Hospital of Nanchang Medical College)

Nanchang, Jiangxi, 330038, China

Location

Jilin Province FAW General ospital

Changchun, Jilin, 130051, China

Location

Frist Aiffiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, 750000, China

Location

Qinghai Province Cardiovascular and Cerebrovascular Disease Specialist Hospital

Xining, Qinghai, 810000, China

Location

Xi'an People's Hospital

Xi'an, Shaanxi, 710018, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Central Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250013, China

Location

People's Hospital of Donga County, Shandong Province

Liaocheng, Shandong, 252200, China

Location

Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Putuo District Central Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

The second hospital of Shanxi medical unversity

Taiyuan, Shanxi, 030001, China

Location

The Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China

Chengdu, Sichuan, 610031, China

Location

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

Location

Tianjin Medical University General Hospital,

Tianjin, Tianjin Municipality, 300052, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

Location

Yili Kazak Autonomous Prefecture Friendship Hospital

Yili Kazak Autonomous Prefecture, Xinjiang, 835000, China

Location

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650102, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Xiongjing Jiang, MD

    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 5, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations