Primary Aldosteronism
Conditions
Keywords
Primary aldosteronism;, Adrenal venous sampling, 68Ga-Pentixafor PET/CT, outcome, multicenter randomized
Brief summary
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)
Detailed description
This is a randomized study 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.
Interventions
DIAGNOSTIC_TEST68Ga-Pentixafor PET/CT
The patients had a normal diet with no special preparation before 68Ga-Pentixafor PET/CT imaging. The dosage of intravenously injected 68Ga-Pentixafor was calculated based on the patient's weight (1.85 MBq \[0.05mCi\]/kg). Local PET/CT scanning of the upper abdomen was performed on a hybrid PET/CT scanner at 10 minutes after the injection of the intravenous tracer, respectively.
Sponsors
The Affiliated Hospital Of Southwest Medical University
West China Hospital
Tongji Hospital
The First Affiliated Hospital of Zhengzhou University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Third Xiangya Hospital of Central South University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Changzhi Medical College
Xiangya Hospital of Central South University
Qifu Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of complete biochemical remission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In surgical population, the proportion of complete biochemical remission | 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. |
| In surgical population, the proportion of complete clinical remission | 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. |
| Daily defined doses (DDD) of antihypertensive agents | At 6-12 months of follow-up. | Prescribed daily dose (DDD) of antihypertensive drugs (including MRA) in each group after 6-12 months of follow-up. |
| The proportion of complete clinical remission | 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. |
| Health Related Quality of Life | At baseline and 6 months of follow-up. | 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. |
| Comparison of adverse events | At baseline and 6 month of follow-up. | 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. |
| Total cost of diagnosis and treatment | At baseline and 6 months of follow-up. | 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. |
Countries
China
Contacts
Primary ContactQifu Li, PhD
Outcome results
None listed