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NCT05105165 Clinical Trial

Regulatory Mechanism of Orphanin FQ in Patients With Chronic Ischemic Heart Failure

Heart Failure Clinical Trial

Official title:
Correlation Between Serum Orphanin FQ and β1-AR Autoantibodies in Patients With Chronic Ischemic Heart Failure and Its Regulatory Mechanism

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05105165
Other study ID # hanyi20210623
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 31, 2022

Study information
Verified date October 2021
Source Second Hospital of Shanxi Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

β 1 adrenergic autoantibody on cardiomyocytes β 1 adrenergic receptor increased the occurrence of malignant arrhythmia in patients with chronic heart failure, accelerated myocardial cell damage, and participated in sudden cardiac death. Our team found for the first time that endogenous orphanin enkephalin promotes arrhythmia after acute myocardial ischemia in rats, and its mechanism includes PKC pathway, regulation of action potential duration and cell membrane surface β 1 adrenoceptor internalization disorder. At the same time, N / OFQ can regulate the level of immune factors, and immune factors participate in the formation of β1-aa. This study will be verified by clinical observation and animal experiments: first, N / OFQ, IL-6 and chronic ischemic heart failure, and β 1-aa; second, relationship between IL-6 gene 572G / C polymorphism and chronic ischemic heart failure correlation of β 1-aa production; last, objective to verify whether N / OFQ is involved in the regulation of IL-6 on chronic ischemic heart failure by knocking out N/ OFQ gene in the animal model of chronic ischemic heart failure. So as to clarify the mechanism of myocardial cell and extracellular injury, and find a new target for the treatment of chronic heart failure.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date December 31, 2022
Est. primary completion date November 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease. Exclusion Criteria: - Restrictive or hypertrophic cardiomyopathy, hypertensive cardiomyopathy, acute myocarditis, acute coronary syndrome or acute myocardial infarction in the last 2 months, valvular disease (except mitral regurgitation secondary to left ventricular dilation).

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Enzyme linked immunosorbent assay
Determination of serum ß 1-aa content

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Second Hospital of Shanxi Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Serum orphanin FQ was determined by enzyme linked immunosorbent assay Serum N/OFQ levels 24 hours
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