Heart FailureNCT05105165
Regulatory Mechanism of Orphanin FQ in Patients With Chronic Ischemic Heart Failure
An observational study of Heart Failure, run by Second Hospital of Shanxi Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Enzyme linked immunosorbent assay
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: During the study period, patients in the Department of Cardiology of the second hospital of Shanxi Medical University were admitted.
Who may be able to join
- Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease.
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Enzyme linked immunosorbent assay
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme linked immunosorbent assayDiagnostic test
Determination of serum β 1-aa content
| Study group | Role | What they receive |
|---|---|---|
| Antibody positive group | Not described Receives: Diagnostic Test: Enzyme linked immunosorbent assay | |
| Antibody negative group | Not described Receives: Diagnostic Test: Enzyme linked immunosorbent assay | |
| Health Group | Not described Receives: Diagnostic Test: Enzyme linked immunosorbent assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum orphanin FQ was determined by enzyme linked immunosorbent assay
Serum N/OFQ levels
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion28 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105165
- Sponsor's protocol ID
- hanyi20210623
- Status last verified
- Oct 2021
- First submitted
- 4 Jul 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Orphanin FQ and β1-AR Autoantibodies in Patients With Chronic Ischemic Heart Failure and Its Regulatory Mechanism
- ClinicalTrials.gov ID
- NCT05105165
- Acronym / sponsor ID
- hanyi20210623
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- During the study period, patients in the Department of Cardiology of the second hospital of Shanxi Medical University were admitted.
Key inclusion criteria (1 listed)
- Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzyme linked immunosorbent assayDetermination of serum β 1-aa content | Diagnostic test | Antibody negative group, Antibody positive group, Health Group |
Primary outcome
Serum orphanin FQ was determined by enzyme linked immunosorbent assay
Time frame: 24 hours
Serum N/OFQ levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Second Hospital of Shanxi Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum orphanin FQ was determined by enzyme linked immunosorbent assay (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.