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AVS After 1mg DST to Determine Subtype in PA

Primary Purpose

Primary Aldosteronism

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dexamethasone 1 MG Oral Tablet

Placebo

About this trial

This is an interventional diagnostic trial for Primary Aldosteronism focused on measuring primary aldosteronism, adrenal venous sampling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 or above, male or female, with legal capacity;
Patients who diagnosed as primary aldosteronism and willing to surgery

Exclusion Criteria:

Pregnant or lactating women
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
Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Sites / Locations

Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AVS after 1mg DST

AVS after placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Daily defined doses of antihypertensive agents

The daily defined doses of antihypertensive agents of patients' blood pressure well controlled

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.

Adverse events

Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

Full Information

NCT ID

NCT04709185

First Posted

January 12, 2021

Last Updated

May 31, 2023

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04709185

Brief Title

AVS After 1mg DST to Determine Subtype in PA

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 8, 2021 (Actual)

Primary Completion Date

October 30, 2022 (Actual)

Study Completion Date

December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Aldosteronism

Keywords

primary aldosteronism, adrenal venous sampling

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AVS after 1mg DST

Arm Type

Experimental

Arm Description

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

Arm Title

AVS after placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 1 MG Oral Tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete biochemical remission

Description

Time Frame

1year

Title

Complete clinical remission

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Daily defined doses of antihypertensive agents

Description

The daily defined doses of antihypertensive agents of patients' blood pressure well controlled

Time Frame

1 year

Title

Successful catheterization rate

Description

Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.

Time Frame

procedure

Title

Adverse events

Description

Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 or above, male or female, with legal capacity; Patients who diagnosed as primary aldosteronism and willing to surgery Exclusion Criteria: Pregnant or lactating women 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 Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH; PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaomu Li, PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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AVS After 1mg DST to Determine Subtype in PA

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