Primary Aldosteronism Clinical Trial
— GAPAOfficial title:
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial
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)
Status | Recruiting |
Enrollment | 320 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: (1)Getting the written informed consent (2)ARR =20 (pg/ml)/ (µIU/ml) or ARR = 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT). (3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (=1cm). Exclusion criteria 1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) =50 nmol/l. 2. PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (=1cm), plasma aldosterone >300pg/ml] 3. Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history] 4. Suspicion of pheochromocytoma or adrenal carcinoma. 5. Patients with actively malignant tumor. 6. Patients who have adrenalectomy history or with adrenocortical insufficiency. 7. Long-term use of glucocorticoids. 8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders. 9. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG=13.3 mmol/L); Obesity (BMI=35 kg/m²) or Underweight (BMI=18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment |
Country | Name | City | State |
---|---|---|---|
China | The First Affilated Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Qifu Li | Changzhi Medical College, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Affiliated Hospital Of Southwest Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, Tongji Hospital, West China Hospital, Xiangya Hospital of Central South University |
China,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of complete biochemical remission | 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. | At 6 months of follow-up. | |
Secondary | The proportion of complete clinical remission | 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. | At 6 months of follow-up. | |
Secondary | In surgical population, the proportion of complete biochemical remission | 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. | At 6 months of follow-up. | |
Secondary | In surgical population, the proportion of complete clinical remission | 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. | At 6 months of follow-up. | |
Secondary | Daily defined doses (DDD) of antihypertensive agents | Prescribed daily dose (DDD) of antihypertensive drugs (including MRA) in each group after 6-12 months of follow-up. | At 6-12 months of follow-up. | |
Secondary | Total cost of diagnosis and treatment | After patients are determined to be enrolled, treatment costs incurred for the diagnostic process will be calculated for each subject. This includes CT,AVS or PET/CT, surgery, medications, etc. | At baseline and 6 months of follow-up. | |
Secondary | Health Related Quality of Life | The quality of life in our patients may be influenced in different ways.AVS is an invasive test, PET/CT does not require any preparation of the patient before the test. Questionnaires of QOL-BREF will be conducted by patients before treatment and at 6-12 months follow-up in each group.This will allow for a detailed analysis of the impact of the two strategies on the quality of life of the patients. | At baseline and 6 months of follow-up. | |
Secondary | Comparison of adverse events | The occurrence of adverse events was recorded, including PET/CT contrast agent allergy, adrenal vein hemorrhage and related adrenal insufficiency, hypertensive emergency, anaphylactic shock, venous thrombosis, pulmonary embolism, etc. | At baseline and 6 month of follow-up. |
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