An Early Phase 1 interventional study of Eprolidone in Chronic Heart Failure Patients, sponsored by Cheng LuFeng,Principal Investigator. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Cheng LuFeng,Principal Investigator · Early Phase 1, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 800 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Cheng LuFeng,Principal Investigator as lead sponsor.
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Exclusion Criteria:
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
Other conventional anti chronic heart failure drugs for the conventional treatment group taking non aldosterone receptor blockers
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.
Expression of Kv1.3 channel protein in Treg cells in circulating blood
Detection of Treg cell activity in venous blood of patients
Time frame: 4 weeks
Levels of aldosterone in blood circulation （pg/mL)
Detection of aldosterone in venous blood of patients by ELISA
Time frame: 4 weeks
The levels of IL-10 and TGF-β in blood circulation （pg/mL)
Detection of plasma inflammatory factors in subjects
Time frame: 4 weeks
Detection of left ventricular Ejection fraction by echocardiography
Echocardiographic detection of cardiac function in patients
Time frame: 4 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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