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

Study Overview
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Brief Summary
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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
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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.

Official Title
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College of Pharmacy, Xinjiang Medical University

Conditions
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Chronic Heart Failure Patients

Intervention / Treatment
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* Drug: Eprolidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Conventional treatment group Eprolidone group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eprolidone intervention in patients with chronic heart failure<br>The Pulidone group received conventional medication combined with 25 mg/day of Eprolidone, gradually increasing to 50 mg/day for 4 consecutive weeks | Drug: Eprolidone<br>* 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.<br>|
| No Intervention: Patients in the conventional treatment group<br>Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of Kv1.3 channel protein in Treg cells in circulating blood | Detection of Treg cell activity in venous blood of patients | 4 weeks | 
| Levels of aldosterone in blood circulation （pg/mL) | Detection of aldosterone in venous blood of patients by ELISA | 4 weeks | 
| The levels of IL-10 and TGF-β in blood circulation （pg/mL) | Detection of plasma inflammatory factors in subjects | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of left ventricular Ejection fraction by echocardiography | Echocardiographic detection of cardiac function in patients | 4 weeks |