Hyperaldosteronism
Conditions
Keywords
Adrenal venous sampling, Hyperaldosteronism, Antecubital approach, Femoral approach, Pathological results
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.
Detailed description
Primary aldosteronism (PA) is one of the most common causes of secondary hypertension, and its most common subtypes are aldosterone-producing adenoma and idiopathic hyperaldosteronism, which account for 95% to 98% of PA. Subtype diagnosis is crucial for the treatment of primary aldosteronism, which conducts the appropriate treatment strategy. Currently, adrenal venous sampling (AVS) serves as the gold standard for subtyping of PA. How to improve the success rate of AVS has been a hot topic in the field of primary aldosteronism. This multicenter registry study intends to combine retrospective analysis and prospective registry to evaluate the success rate and safety of 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 also analyzed in this study.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Aged from 18 to 65 with no limits in sex; 2. Patients with confirmed primary aldosteronism; 3. Patients or their legal representatives sign written informed consent approved by the ethics committee;
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 |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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 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) |
| the cost of the procedure | At AVS procedure | the cost of the procedure |
| pathological results(If the patient underwent adrenalectomy) | 1 week After AVS procedure | Pathological types of primary aldosteronism(to compare the consistency between adrenal venous sampling results and histopathological results if the patients underwent adrenalectomy.) |
| The contrast agent dosage | At AVS procedure | The contrast agent dosage |
Countries
China