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AVS After 1mg DST to Determine Subtype in PA

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ClinicalTrials.gov Identifier: NCT04709185
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 8, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. Complete biochemical remission [ Time Frame: 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.

  2. Complete clinical remission [ Time Frame: 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 :
  1. Daily defined doses of antihypertensive agents [ Time Frame: 1 year ]
    The daily defined doses of antihypertensive agents of patients' blood pressure well controlled

  2. Successful catheterization rate [ Time Frame: procedure ]
    Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation.

  3. Adverse events [ Time Frame: 3 month ]
    Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709185


Contacts
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Contact: Xiaomu Li, PhD 86-21-64041990 li.xiaomu@zs-hospital.sh.cn

Locations
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China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China
Contact: Xiaomu Li, PhD    86-21-64041990    li.xiaomu@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Xiaomu Li, PhD Fudan University
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04709185    
Other Study ID Numbers: 1mgDST AVS
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
primary aldosteronism
adrenal venous sampling
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents