68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism: The GAPA Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- The proportion of complete biochemical rsuccess
研究概览
简要总结
To compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)
详细描述
This is a multicenter randomized noninferiority clinical trial involving patients with primary aldosteronism (PA) patients with adrenal nodule (≥1cm) who completed AVS or 68Ga-Pentixafor PET/CT.We will enroll 320 PA patients with adrenal nodule (≥1cm) .All paticipants will be randomized into 68Ga-Pentixafor PET/CT group(Intervention group) and AVS group(Control group) to compare the long-term outcomes of patients with PA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Biochemical and clinical outcomes were independently assessed by 2 evaluators who were not involved in subtype classification or treatment decisions and were blinded to the randomized diagnostic strategy. Disagreements were resolved by a third independent evaluator.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Inclusion Criteria
- •Participants must meet all of the following criteria:
- •.Ability to understand the trial procedures and provide written informed consent.
- •.Age 18 to 70 years.
- •.Hypertension with a confirmed diagnosis of primary aldosteronism.
- •.Adrenal gland CT or MRI scan showing an adrenal nodule of 1 cm or larger.
- •.Willingness to undergo adrenalectomy if lateralizing primary aldosteronism is identified.
- •A confirmed diagnosis of primary aldosteronism will be defined as a positive screening result and at least one positive aldosterone suppression test. A positive screening result will be defined as an aldosterone-to-renin ratio of ≥20(pg/mL)/(mIU/L) or≥30 (ng/dL)/(ng/mL/hr). A positive aldosterone suppression test will be defined as a plasma aldosterone concentration of≥110 pg/mL after the captopril challenge test or ≥80pg/mL after the seated saline infusion test.
排除标准
- •Participants will be excluded if any of the following criteria are met:
- •.Autonomous cortisol secretion,defined as a serum cortisol levels ≥ 50 nmol/L after a 1-mg overnight dexamethasone suppression test.
- •.Fulfillment of prespecified criteria for bypassing AVS, defined as age younger than 35 years, typical features of aldosterone-producing adenoma, plasma aldosterone concentration >300 pg/mL, spontaneous hypokalemia, and a unilateral low-density adrenal nodule >1 cm on CT.
- •.Compliacted with other secondary hypertension (such as Cushing's syndrome, renal artery stenosis, but not including obstructive sleep apnea syndrome).
- •.Onset of hypertension before 20 years of age with hypokalemia and a family history suggestive of familial hyperaldosteronism, Liddle syndrome, or another hereditary form of hypertension.
- •. Adrenal nodules with imaging characteristics suggestive of pheochromocytoma, adrenocortical carcinoma, adrenal cysts, adrenal hematomas, or adrenal myelolipomas.
- •.Active malignant disease.
- •.Previous adrenal surgery.
- •.Adrenal insufficiency requiring glucocorticoid replacement therapy.
- •.Long-term glucocorticoid therapy that cannot be discontinued.
- •.Allergy or intolerance to contrast media or contraindication to AVS.
- •.Pregnancy or lactation.
- •.Alcohol or drug abuse, or psychiatric illness that would interfere with trial participation.
- •.New York Heart Association class III or IV heart failure.
- •.Hospitalization for worsening chronic heart failure within the previous 3 months.
- •.Stroke or acute coronary syndrome within the previous 3 months.
- •.Severe anemia, defined as hemoglobin <6 g/dl.
- •.Severe liver disease, defined as alanine aminotransferase ≥3 times the upper limit of the normal range.
- •.Severe kidney disease, defined as dialysis treatment or an estimated glomerular filtration rate <30 mL/min/1.73 m².
- •.Systemic inflammatory response syndrome.
- •.Uncontrolled diabetes, defined as fasting blood glucose ≥13.3 mmol/L.
- •.Severe obesity, defined as a body-mass index ≥35 kg/m², or underweight status, defined as a body-mass index ≤18 kg/m².
- •.Untreated aneurysm or any other condition that, in the investigator's judgment, would interfere with safe participation or continued treatment for primary aldosteronism.
研究组 & 干预措施
AVS group
Patients divided into AVS group need to undergo AVS to guide subsequent treatment based on the results
68Ga-Pentixafor PET/CT group
Patients divided into 68Ga-Pentixafor PET/CT group need to undergo 68Ga-Pentixafor PET/CT examination and guide subsequent treatment based on the results
干预措施: 68Ga-Pentixafor PET/CT (Diagnostic Test)
结局指标
主要结局
The proportion of complete biochemical rsuccess
时间窗: At 6 months of follow-up.
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
The proportion of complete biochemical remission
时间窗: At 6 months of follow-up.
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
次要结局
- The proportion of complete clinical success(At 6 months of follow-up.)
- The change in the Defined Daily Dose (DDD) of antihypertensive medications(At 6 months of follow-up.)
- In surgical population, the proportion of complete biochemical remission(At 6 months of follow-up.)
- In surgical population, the proportion of complete clinical remission(At 6 months of follow-up.)
- Total cost of diagnosis and treatment(At baseline and 6 months of follow-up.)
- Comparison of adverse events(At baseline and 6 month of follow-up.)
- Daily defined doses (DDD) of antihypertensive agents(At 6-12 months of follow-up.)
- Health Related Quality of Life(At baseline and 6 months of follow-up.)
- The proportion of complete clinical remission(At 6 months of follow-up.)
研究者
Qifu Li
Principal Investigator
First Affiliated Hospital of Chongqing Medical University