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Compare Outcomes of AVS With or Without ACTH Stimulation

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ClinicalTrials.gov Identifier: NCT04461535
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

Brief Summary:
To compare the effect of different procedures of AVS(with or without ACTH stimulation) on the long-term outcomes of patients with PA

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Drug: Adrenocorticotropic hormone Not Applicable

Detailed Description:

This is a prospective, randomized, double-blinded study involving 200 patients with primary aldosteronism(PA) who completed AVS.

All paticipants will be randomized into ACTH-stimulated group(Intervention group,n=100) and ACTH-unstimulated group(Control group,n=100) and to compare the long-term outcomes of patients with PA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Adrenal Venous Sampling With or Without Adrenocorticotropic Hormone Stimulation to Determine Outcomes in Primary Aldosteronism: an Outcome-based Randomized Study
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: AVS with ACTH stimulation
Patients divided into AVS with ACTH stimulation group need to undergo stimulation with a continuous cosyntropin infusion.
Drug: Adrenocorticotropic hormone
Patients divided into Intervention group need to undergo stimulation with a continuous cosyntropin infusion (50 μg/h started 30 minutes before sampling during AVS). Right and left adrenal venous blood and corresponding peripheral venous blood should be sampled sequentially.
Other Name: ACTH

No Intervention: AVS without ACTH stimulation
Patients divided into AVS without ACTH stimulation group take the same procedure of AVS with a continuous saline infusion.



Primary Outcome Measures :
  1. Compare the rate of complete biochemical remission between two groups [ Time Frame: At 12 months of follow-up. ]
    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. Complete clinical remission [ Time Frame: At 12 months of follow-up. ]
    The proportion of complete clinical remission according to PASO consensus criteria.Clinical outcomes were determined by the blood pressure response to treatment and the number and dosage of antihypertensive medications.

  2. Daily defined doses (DDD) of antihypertensive agents [ Time Frame: At 12 months of follow-up. ]
    When patients' blood pressure get well controlled(SBP<140mmHg and DBP<90mmHg), calculate the daily defined doses (DDD) of antihypertensive agents.

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

  4. Adverse events [ Time Frame: At baseline and 1 month of follow-up. ]
    Record the occurrence of adverse events, including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

  5. The health-related quality of life [ Time Frame: At baseline and 12 months of follow-up. ]
    Compare the quality of life score between two groups,using EuroQol-5 Dimension Visual Analogue Scale (VAS) score.The minimum and maximum values are 0 and 100,respectively. And higher scores mean a better outcome.

  6. bilateral adosterone inhibiton (BAS) in AVS [ Time Frame: At baseline ]
    calculate the BAS rate in AVS



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand the whole process of the trial and voluntarily accept randomized grouping, intervention and follow-up;
  2. Voluntarily participate in the study and sign the informed consent form, willing to complete all follow-ups as required;
  3. Age 18 or above, male or female, with legal capacity;
  4. Hypertension patients with positive PA screening (ARR>10) and at least one positive PA diagnostic tests (CCT, SIT or FST);

Exclusion Criteria:

Patients with one of the following conditions cannot be included in this study:

  1. Pregnant or lactating women
  2. Patients with a history of malignant tumors
  3. Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH;
  4. PA combined with Cushing syndrome (including subclinical Cushing);
  5. Considering familiar hyperaldosteronism or adrenocortical carcinoma;
  6. Drugs which have a relevant effect on the treatment prescribed in this study are currently used and cannot be stopped or changed, or it may cause high blood pressure and hypertension, such as glucocorticoids.
  7. Complicated with severe heart disease (including pacemaker implantation), severe cardiac dysfunction, severe anemia (Hb<60g/L), stroke or acute coronary syndrome within 3 months, severe ascites and liver cirrhosis at baseline, etc., which can seriously interfere with subsequent treatment of PA or health-related quality of life assessment.
  8. Alcoholics, drug users, and mentally disabled patients.

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): NCT04461535


Contacts
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Contact: Qifu Li, PhD +86 023-89011552 liqifu@yeah.net

Locations
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China, Chongqing
The First Affilated Hospital of Chongqing Medical University Recruiting
Chongqing, Chongqing, China, 400016
Contact: Qifu Li, M.D., PhD.    023-89011552    liqifu@yeah.net   
Contact: Ying Song, M.D.    023-89011552    shuiyunying@126.com   
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Study Chair: Qifu Li, PhD the Chongqing Primary Aldosteronism Study (CONPASS) Group
Publications of Results:

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Responsible Party: Qifu Li, Professor.Qifu Li, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04461535    
Other Study ID Numbers: ADOPA study
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 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 Qifu Li, Chongqing Medical University:
primary aldosteronism
adrenal venous sampling
Additional relevant MeSH terms:
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Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action