AVS After 1mg DST to Determine Subtype in PA

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04709185

Collaborator

(none)

Enrollment

Location

Arms

23.7

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Drug: Dexamethasone 1 MG Oral Tablet Drug: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jan 8, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Complete biochemical remission [1year]
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 [1 year]
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 [1 year]
The daily defined doses of antihypertensive agents of patients' blood pressure well controlled
Successful catheterization rate [procedure]
Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.
Adverse events [3 month]
Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai		China

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Principal Investigator: Xiaomu Li, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT04709185

Other Study ID Numbers:

1mgDST AVS

First Posted:

Jan 14, 2021

Last Update Posted:

May 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shanghai Zhongshan Hospital

primary aldosteronism

adrenal venous sampling

Additional relevant MeSH terms:

Hyperaldosteronism

Dexamethasone

Study Results

No Results Posted as of May 5, 2022