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.
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, yet its optimal diagnostic and therapeutic strategies remain challenging. Adrenal venous sampling (AVS) is regarded as the gold standard for subtype differentiation; however, important clinical, technical, and methodological issues have not been systematically addressed. This study is designed to comprehensively evaluate AVS and its clinical implications, aiming to elucidate the relationship between AVS-guided diagnosis and management of PA and long-term clinical and biochemical outcomes, while refining AVS protocols, standardizing clinical practice, optimizing therapeutic decision-making, and ultimately improving patient management and prognosis.
Study Type
OBSERVATIONAL
Enrollment
5,000
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.
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 procedure
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
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
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
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
Time of the procedure
Time of the procedure
Time frame: At AVS procedure
Time of fluoroscopy
Time of fluoroscopy
Time frame: At AVS procedure
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The first affiliated hospital of USTC
Hefei, Anhui, China
RECRUITINGChuiyangliu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Central Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGChongqing General Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGPeople's Hospital Affiliated to ChongqingThree Gorges Medical college
Chongqing, Chongqing Municipality, China
RECRUITING...and 66 more locations
The contrast agent dosage
The contrast agent dosage
Time frame: At AVS procedure
the incidence of complications
Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc)
Time frame: 1 week after AVS procedure
the cost of the procedure
the cost of the procedure
Time frame: At AVS procedure
Change in 24-hour ambulatory systolic blood pressure
The difference in average systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) between baseline and each follow-up time point.
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in 24-hour ambulatory diastolic blood pressure
The difference in average diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) bewteen baseline and each follow-up time point.
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in office systolic blood pressure
The difference in systolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in office diastolic blood pressure
The difference in diastolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in antihypertensive medication burden
The change in the number and/or dosage of antihypertensive medications taken by patients between baseline and each follow-up time point
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in urinary albumin-to-creatinine ratio (UACR)
The difference in urinary albumin-to-creatinine ratio measured at baseline and at each follow-up time point
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in left ventricular mass index (LVMI)
The change in left ventricular mass index, as assessed by echocardiography, from baseline to each follow-up time point.
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Change in pulse wave velocity (PWV) from baseline
The change in pulse wave velocity measured between baseline and each follow-up time point。
Time frame: At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment
Clinical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria
Clinical outcomes will be assessed at each follow-up visit afteradrenal surgery according to the PASO consensus criteria. Outcomes will be categorized as: (1)Complete clinical success: normal blood pressure without the need for any antihypertensive medication. (2)Partial clinical success: improvement in blood pressure and/or a reduction in the number or dosage of antihypertensive medications. (3)Absent clinical success: no improvement in blood pressure or antihypertensive medication burden.
Time frame: At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery
Biochemical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria
Biochemical outcomes will be assessed at each follow-up visit after adrenal surgery according to the PASO consensus classification. Outcomes will be categorized as:(1)Complete biochemical success: normal serum potassium levels and a normalized aldosterone-to-renin ratio (ARR) without the need for potassium supplementation.(2)Partial biochemical success: improvement in biochemical parameters without full normalization.(3)Absent biochemical success: no improvement in biochemical markers compared to baseline.
Time frame: At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery
Major adverse cardiovascular events (MACE)
Incidence of major adverse cardiovascular events (MACE), including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death.
Time frame: At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure