Liver CirrhosisNCT03158701
Prevelance of Fragmented QRS Complex and Prolonged QT Interval in Cirrhotic Patients
An observational study of Liver Cirrhosis, run by Assiut University.
Trial summary
.Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities. .Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To evaluate the relationship between the presence of FQRS complex and prolonged QT interval in ECG in cirrhotic patients and its correlation with the severity of the disease according to the pugh-child score.
Who may be able to join
- All cirrhotic patients based on history and clinical diagnosis
Who cannot join
- Patients known to be rheumatic heart disease
- Patients known to be hypertensive
- patients with documented significant coronary artery disease
- patients taking drugs that affect QT interval
About this study
Official title: Prevelance of Fragmented QRS Complex and Prolonged QT Interval in Cirrhotic Patients and Its Correlation With the Severity of the Disease
.Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities.
.Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection.
Read more
The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels.
.As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and prolongation of the corrected QT interval has been documented in most of the cases with liver cirrhosis (LC) and its prevalence increases with the severity of the disease
Read the detailed description
.Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities.
.Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection.
The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels.
.As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and prolongation of the corrected QT interval has been documented in most of the cases with liver cirrhosis (LC) and its prevalence increases with the severity of the disease.
.Fragmented QRS (fQRS) is a convenient marker of myocardial scar evaluated by 12-lead electrocardiogram (ECG) recording. fQRS is defined as additional spikes within the QRS complex. In patients with CAD, fQRS was associated with myocardial scar detected by single photon emission tomography and was a predictor of cardiac events. fQRS was also a predictor of mortality and arrhythmic events in patients with reduced left ventricular function. The usefulness of fQRS for detecting myocardial scar and for identifying high-risk patients has been expanded to various cardiac diseases, such as cardiac cirrhosis, arrhythmogenic right ventricular cardiomyopathy, acute coronary syndrome. fQRS can be caused by zigzag conduction around the scarred myocardium, resulting in multiple spikes within the QRS complex .
- Conditions
- Liver Cirrhosis
- Keywords
- evaluation
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the measurement that will be used is the presence of fragmented QRS complex and prolonged QT interval in Electrocardiography in patients with liver cirrhosis
Primary (main) out come:
To evaluate the relationship between the presence of FQRS complex and prolonged QT interval in ECG in cirrhotic patients and its correlation with the severity of the disease according to the pugh-child score.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Refaat Edwar Nasrallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158701
- Sponsor's protocol ID
- assiut university 7000
- Status last verified
- May 2017
- First submitted
- 14 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Fragmented QRS Complex and Prolonged QT Interval in Cirrhotic Patients and Its Correlation With the Severity of the Disease
- ClinicalTrials.gov ID
- NCT03158701
- Acronym / sponsor ID
- assiut university 7000
- Conditions
- Liver Cirrhosis
- Keywords
- evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 18 May 2017 (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.
.Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities.
.Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection.
The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels.
.As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and prolongation of the corrected QT interval has been documented in most of the cases with liver cirrhosis (LC) and its prevalence increases with the severity of the disease
Detailed description
.Cardiac affection in liver cirrhosis is a clinical condition characterized by impaired diastolic relaxation and contractility with electrophysiological abnormalities.
.Cirrhotic patients with cardiac abnormality have higher mortality rates compared to patients without cardiac affection.
The suggested pathophysiologic mechanisms of cardiac affection in cirrhotic patients are; alterations in the beta-adrenergic signaling pathway and, myocardial fibrosis formation, sympathetic nervous system activation and changes in ion channels.
.As a component of cardiac involvement in cirrhotic patients fragmented QRS complex and prolongation of the corrected QT interval has been documented in most of the cases with liver cirrhosis (LC) and its prevalence increases with the severity of the disease.
.Fragmented QRS (fQRS) is a convenient marker of myocardial scar evaluated by 12-lead electrocardiogram (ECG) recording. fQRS is defined as additional spikes within the QRS complex. In patients with CAD, fQRS was associated with myocardial scar detected by single photon emission tomography and was a predictor of cardiac events. fQRS was also a predictor of mortality and arrhythmic events in patients with reduced left ventricular function. The usefulness of fQRS for detecting myocardial scar and for identifying high-risk patients has been expanded to various cardiac diseases, such as cardiac cirrhosis, arrhythmogenic right ventricular cardiomyopathy, acute coronary syndrome. fQRS can be caused by zigzag conduction around the scarred myocardium, resulting in multiple spikes within the QRS complex .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate the relationship between the presence of FQRS complex and prolonged QT interval in ECG in cirrhotic patients and its correlation with the severity of the disease according to the pugh-child score.
Key inclusion criteria (1 listed)
- All cirrhotic patients based on history and clinical diagnosis
Key exclusion criteria (4 listed)
- Patients known to be rheumatic heart disease
- Patients known to be hypertensive
- patients with documented significant coronary artery disease
- patients taking drugs that affect QT interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the measurement that will be used is the presence of fragmented QRS complex and prolonged QT interval in Electrocardiography in patients with liver cirrhosis
Time frame: one year
Primary (main) out come: To evaluate the relationship between the presence of FQRS complex and prolonged QT interval in ECG in cirrhotic patients and its correlation with the severity of the disease according to the pugh-child score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- 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 Liver Cirrhosis, run by Assiut 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 4 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 18 May 2017. 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?
the measurement that will be used is the presence of fragmented QRS complex and prolonged QT interval in Electrocardiography in patients with liver cirrhosis (time frame: one year). 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 18 May 2017.