Clinical trial

Adrenal Venous Sampling Under 1 mg Overnight Dexamethasone Suppression Test to Determine Subtype in Primary Aldosteronism,a Single Center, Randomized, Double Blended, Placebo Controlled Clinical Trail

Name
1mgDST AVS
Description
To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA
Trial arms
Trial start
2021-01-08
Estimated PCD
2022-10-30
Trial end
2022-12-30
Status
Completed
Treatment
Dexamethasone 1 MG Oral Tablet
oral 1 mg dexamethasone at 23:00-24:00 the night before AVS
Arms:
AVS after 1mg DST
Placebo
oral placebo at 23:00-24:00 the night before AVS
Arms:
AVS after placebo
Size
110
Primary endpoint
Complete biochemical remission
1year
Complete clinical remission
1 year
Eligibility criteria
Inclusion Criteria: 1. Age 18 or above, male or female, with legal capacity; 2. Patients who diagnosed as primary aldosteronism and willing to surgery Exclusion Criteria: 1. Pregnant or lactating women 2. Patients with a history of malignant tumors or complicated with severe heart disease, eGFR\<30ml/min/1.73m2, severe anemia (Hb\<60g/L), stroke or acute coronary syndrome within 3 months, severe liver disease 3. Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH; 4. PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}
Updated at
2023-06-01

1 organization

1 product

1 drug

1 indication