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China National Study of Adrenal Venous Sampling

ConditionHyperaldosteronism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • adrenal venous sampling

    Procedure/Surgery

    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.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Adrenal Venous Sampling1 intervention

Trial outcomes

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)

Time frame
At AVS procedure

Secondary outcomes

1

The success rate of left 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)

Time frame
At AVS procedure
2

The success rate of right 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)

Time frame
At AVS procedure
3

Selection of intraoperative catheter

Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach

Time frame
At AVS procedure
4

Time of the procedure

Time of the procedure

Time frame
At AVS procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: