NCT05105165

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 3, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

July 4, 2021

Last Update Submit

October 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum orphanin FQ was determined by enzyme linked immunosorbent assay

    Serum N/OFQ levels

    24 hours

Study Arms (3)

Antibody positive group

Diagnostic Test: Enzyme linked immunosorbent assay

Antibody negative group

Diagnostic Test: Enzyme linked immunosorbent assay

Health Group

Diagnostic Test: Enzyme linked immunosorbent assay

Interventions

Determination of serum β 1-aa content

Antibody negative groupAntibody positive groupHealth Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 4, 2021

First Posted

November 3, 2021

Study Start

November 1, 2021

Primary Completion

November 28, 2022

Study Completion

December 31, 2022

Last Updated

November 3, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share