CHina Adrenal Venous saMPling InvestigatiON
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
About this trial
Primary aldosteronism (PA) is a major cause of secondary hypertension, yet its optimal diagnosis and management remain challenging. This study comprehensively evaluates adrenal venous sampling (AVS), addressing key clinical, technical, and methodological issues, and aims to clarify the relationship between AVS-guided management and long-term clinical and biochemical outcomes to optimize patient care and prognosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with confirmed primary aldosteronism;
Patients undergoing adrenal venous sampling for subtype classification of primary aldosteronism.
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
All patients with confirmed primary aldosteronism underwent adrenal venous sampling.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
adrenal venous sampling
Procedure/SurgeryPatients 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
5,000 Participants
are divided into 1 treatment groupGroup A: Adrenal Venous Sampling1 intervention
Trial outcomes
Primary outcomes
1
Major adverse cardiovascular events (MACE) at 1-year follow-up
Incidence of major adverse cardiovascular events (MACE) at 1-year follow-up, including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death.
Time frame
1 year after AVS procedureSecondary 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 procedure2
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 procedure3
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 procedure4
Selection of intraoperative catheter
Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach
Time frame
At AVS procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov