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

October 25, 2021 updated by: Zheng Guo, Second Hospital of Shanxi Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

During the study period, patients in the Department of Cardiology of the second hospital of Shanxi Medical University were admitted.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Antibody positive group
Diagnostic test: Enzyme linked immunosorbent assay
Determination of serum β 1-aa content
Antibody negative group
Diagnostic test: Enzyme linked immunosorbent assay
Determination of serum β 1-aa content
Health Group
Diagnostic test: Enzyme linked immunosorbent assay
Determination of serum β 1-aa content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum orphanin FQ was determined by enzyme linked immunosorbent assay
Time Frame: 24 hours
Serum N/OFQ levels
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Shanxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 28, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanyi20210623

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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