AVS After 1mg DST to Determine Subtype in PA

NCT04709185 | Completed

• 1 other identifier: 1mgDST AVS
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Aldosteronism

Keywords

primary aldosteronism; adrenal venous sampling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Daily defined doses of antihypertensive agents

  1 year

• Successful catheterization rate

  procedure

• Adverse events

  3 month

Study Arms (2)

AVS after 1mg DST

EXPERIMENTAL

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

Drug: Dexamethasone 1 MG Oral Tablet

AVS after placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dexamethasone 1 MG Oral Tablet DRUG

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

AVS after 1mg DST

Placebo DRUG

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

AVS after placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Dexamethasone; Tablets

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Xiaomu Li, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 8, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)