AVS After 1mg DST to Determine Subtype in PA

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709185
• Other study ID #: 1mgDST AVS
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA

Description:

All paticipants will be randomly divided into 1mg DST group(Intervention group,n=43) and placebo group(Control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with PA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Intervention

Drug:
• Dexamethasone 1 MG Oral Tablet
oral 1 mg dexamethasone at 23:00-24:00 the night before AVS
• Placebo
oral placebo at 23:00-24:00 the night before AVS

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete biochemical remission	Compare the rate of complete biochemical remission between two groups. 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.	1year
Primary	Complete clinical remission	Compare the rate of complete clinical remission between two groups. 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.	1 year
Secondary	Daily defined doses of antihypertensive agents	The daily defined doses of antihypertensive agents of patients' blood pressure well controlled	1 year
Secondary	Successful catheterization rate	Calculate the successful rate of catheterization. Successful catheterization was defined as SI=2 without ACTH stimulation or SI=3 with ACTH stimulation.	procedure
Secondary	Adverse events	Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.	3 month