Adrenalectomy, Adrenal Venous Sampling, Hyperaldosteronism
Conditions
Keywords
Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Main adverse cardiovascular events
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREadrenal 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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with confirmed primary aldosteronism; 2. Patients undergoing adrenal venous sampling for subtype classification of primary aldosteronism.
Exclusion criteria
1. Severe comorbidity, including stroke, myocardial infarction, heart failure, severe valvular heart disease, liver cirrhosis, and metastatic tumor within the previous 3 months； 2. An estimated glomerular filtration rate \<45 ml/min/1.73 m2, or serum creatinine \>176 μmol/L； 3. Patients who refuse adrenalectomy; 4. Suspected of having an adrenocortical carcinoma; 5. Allergy to contrast agent; 6. Pregnant, nursing, or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) at 1-year follow-up | 1 year after AVS procedure | Incidence of major adverse cardiovascular events (MACE) at 1-year follow-up, including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in office diastolic blood pressure | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The difference in diastolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point |
| The success rate of left adrenal venous sampling | At AVS procedure | Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation) |
| The success rate of right adrenal venous sampling | At AVS procedure | Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation) |
| The success rate of bilateral adrenal venous sampling | At AVS procedure | Successful sampling will be defined by high selectivity index (cortisol in the adrenal vein/cortisol in inferior vena cava \>2 without ACTH simulation) |
| Selection of intraoperative catheter | At AVS procedure | Types of catheter at the time of Adrenal Venous Sampling via antecubital approach or femoral approach |
| Time of the procedure | At AVS procedure | Time of the procedure |
| Time of fluoroscopy | At AVS procedure | Time of fluoroscopy |
| The contrast agent dosage | At AVS procedure | The contrast agent dosage |
| the incidence of complications | 1 week after AVS procedure | Complications related to adrenal vein cannulations (adrenal vein hematoma, inferior vena cava dissection, puncture site hematoma, etc) |
| Change in office systolic blood pressure | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The difference in systolic blood pressure measured during clinic visits (office blood pressure) between baseline and each follow-up time point |
| Change in 24-hour ambulatory systolic blood pressure | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The difference in average systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) between baseline and each follow-up time point. |
| Change in 24-hour ambulatory diastolic blood pressure | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The difference in average diastolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) bewteen baseline and each follow-up time point. |
| Change in antihypertensive medication burden | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The change in the number and/or dosage of antihypertensive medications taken by patients between baseline and each follow-up time point |
| Change in urinary albumin-to-creatinine ratio (UACR) | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The difference in urinary albumin-to-creatinine ratio measured at baseline and at each follow-up time point |
| Change in left ventricular mass index (LVMI) | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The change in left ventricular mass index, as assessed by echocardiography, from baseline to each follow-up time point. |
| Change in pulse wave velocity (PWV) from baseline | At 1, 3, 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after treatment | The change in pulse wave velocity measured between baseline and each follow-up time point。 |
| Clinical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria | At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery | 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. |
| Biochemical Outcome According to Primary Aldosteronism Surgical Outcome (PASO) Criteria | At 6, 12, and 18 months; and 2, 3, 4, 5, and 10 years after surgery | 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. |
| Major adverse cardiovascular events (MACE) | At 6 and 18 months; and 2, 3, 4, 5, and 10 years after AVS procedure | Incidence of major adverse cardiovascular events (MACE), including stroke, heart failure, severe arrhythmias, renal failure, myocardial infarction, and death. |
| the cost of the procedure | At AVS procedure | the cost of the procedure |
Countries
China
Contacts
Primary ContactHui Dong, MD
Backup ContactXiongjing Jiang, MD
Outcome results
None listed