search
Back to results

Clinical Study on the Immunomodulatory Effect of Eprolidone on Patients With Chronic Heart Failure

Primary Purpose

Chronic Heart Failure Patients

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Eprolidone
Sponsored by
Cheng LuFeng,Principal Investigator
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure Patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sign informed consent form, NYHA Level I, Level II Ш The left ventricular ejection fraction (LVEF) measured by radionuclide ventriculography (RNVG) after diagnosis of chronic congestive heart failure (CHF) is ≤ 45%. Exclusion Criteria: Age<18 or>80, serum creatinine level>2.5 mg/deciliter, blood potassium level>5.0 mmol/liter, surgical treatment for valvular heart disease, contraindications to the study drug, use of other aldosterone receptor antagonists, malignant tumors and other life-threatening non cardiac diseases, legally incapacitated patients, history of drug and alcohol abuse, pregnant and postpartum women, and women breastfeeding during the study period. The subjects were divided into a conventional treatment group and an epridone group, with the conventional treatment group taking other conventional anti chronic heart failure drugs other than aldosterone receptor blockers as the baseline. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Eprolidone intervention in patients with chronic heart failure

    Patients in the conventional treatment group

    Arm Description

    The Pulidone group received conventional medication combined with 25 mg/day of Eprolidone, gradually increasing to 50 mg/day for 4 consecutive weeks

    Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers

    Outcomes

    Primary Outcome Measures

    Expression of Kv1.3 channel protein in Treg cells in circulating blood
    Detection of Treg cell activity in venous blood of patients
    Levels of aldosterone in blood circulation (pg/mL)
    Detection of aldosterone in venous blood of patients by ELISA
    The levels of IL-10 and TGF-β in blood circulation (pg/mL)
    Detection of plasma inflammatory factors in subjects

    Secondary Outcome Measures

    Detection of left ventricular Ejection fraction by echocardiography
    Echocardiographic detection of cardiac function in patients

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    June 28, 2023
    Sponsor
    Cheng LuFeng,Principal Investigator
    Collaborators
    First Affiliated Hospital of Xinjiang Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05924958
    Brief Title
    Clinical Study on the Immunomodulatory Effect of Eprolidone on Patients With Chronic Heart Failure
    Official Title
    College of Pharmacy, Xinjiang Medical University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2026 (Anticipated)
    Study Completion Date
    September 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cheng LuFeng,Principal Investigator
    Collaborators
    First Affiliated Hospital of Xinjiang Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Chronic heart failure has a high incidence, mortality rate, and disability rate. There are approximately 4 million heart failure patients among adults aged 35-74 in China, which has become a major public health issue. In this context, accelerating the development of drugs for treating chronic heart failure has become an urgent and urgent problem to be solved. Therefore, revealing the pathogenic mechanism of chronic heart failure, finding specific drug intervention targets, conducting personalized and precise diagnosis and treatment, reducing the economic burden of patients, and promoting national economic development have significant practical significance and far-reaching strategic impact. Heart failure, as the final stage of various cardiovascular diseases, is difficult to recover once it occurs, so it is of great benefit to achieve "early detection and treatment" for heart failure. At present, biomarkers are mainly used for the diagnosis and prognosis of heart failure, and there are very few biomarkers that provide early warning information. Therefore, it is urgent to find biomarkers that can provide early warning effects. This project focuses on the effect of Eprolidone on the activity of regulatory T cells (Treg), expanding the selection of heart failure treatment drugs, improving drug efficacy, avoiding ineffective treatment, and reducing adverse reactions of the drugs. By carrying out high-quality and precise treatment, we aim to promote the update of the diagnosis and treatment guidelines for chronic heart failure, and provide treatment plans for the prevention and treatment of chronic heart failure and the formulation and adjustment of national medical and health policies.
    Detailed Description
    Recruit participants subjects and sign a written informed consent form. Randomly divide the participants into a conventional treatment group and an epridone group. The conventional treatment group received other conventional anti chronic heart failure drugs that were not aldosterone receptor blockers, and the baseline was taken. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.The participants' venous blood was drawn once a week to test the participants' cardiac function and related immunological indicators.Regularly follow up participants to compare adverse reactions and clinical endpoints.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Heart Failure Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Conventional treatment group Eprolidone group
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Eprolidone intervention in patients with chronic heart failure
    Arm Type
    Experimental
    Arm Description
    The Pulidone group received conventional medication combined with 25 mg/day of Eprolidone, gradually increasing to 50 mg/day for 4 consecutive weeks
    Arm Title
    Patients in the conventional treatment group
    Arm Type
    No Intervention
    Arm Description
    Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers
    Intervention Type
    Drug
    Intervention Name(s)
    Eprolidone
    Intervention Description
    This study assessed the effect of eplerenone on circulating Treg cells in patients with chronic heart failure by detecting the level of aldosterone in venous blood and the activity of Treg cells and the level of inflammatory factors related to it after taking drugs.
    Primary Outcome Measure Information:
    Title
    Expression of Kv1.3 channel protein in Treg cells in circulating blood
    Description
    Detection of Treg cell activity in venous blood of patients
    Time Frame
    4 weeks
    Title
    Levels of aldosterone in blood circulation (pg/mL)
    Description
    Detection of aldosterone in venous blood of patients by ELISA
    Time Frame
    4 weeks
    Title
    The levels of IL-10 and TGF-β in blood circulation (pg/mL)
    Description
    Detection of plasma inflammatory factors in subjects
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Detection of left ventricular Ejection fraction by echocardiography
    Description
    Echocardiographic detection of cardiac function in patients
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign informed consent form, NYHA Level I, Level II Ш The left ventricular ejection fraction (LVEF) measured by radionuclide ventriculography (RNVG) after diagnosis of chronic congestive heart failure (CHF) is ≤ 45%. Exclusion Criteria: Age<18 or>80, serum creatinine level>2.5 mg/deciliter, blood potassium level>5.0 mmol/liter, surgical treatment for valvular heart disease, contraindications to the study drug, use of other aldosterone receptor antagonists, malignant tumors and other life-threatening non cardiac diseases, legally incapacitated patients, history of drug and alcohol abuse, pregnant and postpartum women, and women breastfeeding during the study period. The subjects were divided into a conventional treatment group and an epridone group, with the conventional treatment group taking other conventional anti chronic heart failure drugs other than aldosterone receptor blockers as the baseline. The epridone group received conventional medication combined with 25 mg/day of epridone, gradually increasing to 50 mg/day for 4 consecutive weeks.

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study on the Immunomodulatory Effect of Eprolidone on Patients With Chronic Heart Failure

    We'll reach out to this number within 24 hrs