AVS After 1mg DST to Determine Subtype in PA

NCT ID: NCT04709185

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2022-12-30

Brief 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

Detailed 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.

Conditions

Primary Aldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

AVS after 1mg DST

Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS

Group Type: EXPERIMENTAL

Dexamethasone 1 MG Oral Tablet

Intervention Type: DRUG

oral 1 mg dexamethasone at 23:00-24:00 the night before AVS

AVS after placebo

Patients divided into AVS after placebo group need to oral placebo the night before AVS

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral placebo at 23:00-24:00 the night before AVS

Interventions

Dexamethasone 1 MG Oral Tablet

oral 1 mg dexamethasone at 23:00-24:00 the night before AVS

Intervention Type: DRUG

Placebo

oral placebo at 23:00-24:00 the night before AVS

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaomu Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital, Fudan University

Shanghai, , China

Countries

China

Other Identifiers

1mgDST AVS

Identifier Type: -

Identifier Source: org_study_id