AVS After 1mg DST to Determine Subtype in PA

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

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

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: Dexamethasone 1 MG Oral Tablet; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AVS after 1mg DST; Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS	Drug: Dexamethasone 1 MG Oral Tablet; oral 1 mg dexamethasone at 23:00-24:00 the night before AVS
Placebo Comparator: AVS after placebo; Patients divided into AVS after placebo group need to oral placebo the night before AVS	Drug: Placebo; oral placebo at 23:00-24:00 the night before AVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily defined doses of antihypertensive agents	The daily defined doses of antihypertensive agents of patients' blood pressure well controlled	1 year
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
Adverse events	Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.	3 month

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiaomu Li, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: primary aldosteronism; adrenal venous sampling
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 1mgDST AVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No