Clinical trial NCT05924958: 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
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Heart Failure Patients
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2023-06-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Conventional treatment group Eprolidone group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Expression of Kv1.3 channel protein in Treg cells in circulating blood
timeFrame: 4 weeks
measure: Levels of aldosterone in blood circulation （pg/mL)
timeFrame: 4 weeks
measure: The levels of IL-10 and TGF-β in blood circulation （pg/mL)
timeFrame: 4 weeks
Secondary outcomes:
measure: Detection of left ventricular Ejection fraction by echocardiography
timeFrame: 4 weeks
Other outcomes:
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