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Prevelance of Fragmented QRS Complex and Prolonged QT Interval in Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT03158701
Recruitment Status : Unknown
Verified May 2017 by Fady Refaat Edwar Nasrallah, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Fady Refaat Edwar Nasrallah, Assiut University

Study Description
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Brief 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.

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


Condition or disease
Liver Cirrhosis

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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevelance of Fragmented QRS Complex and Prolonged QT Interval in Cirrhotic Patients and Its Correlation With the Severity of the Disease
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • All cirrhotic patients based on history and clinical diagnosis

Exclusion Criteria:

  1. Patients known to be rheumatic heart disease
  2. Patients known to be hypertensive
  3. patients with documented significant coronary artery disease
  4. patients taking drugs that affect QT interval
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fady Refaat Edwar Nasrallah, internal medicine resident,Assiut University hospital, Assiut University
ClinicalTrials.gov Identifier: NCT03158701    
Other Study ID Numbers: assiut university 7000
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fady Refaat Edwar Nasrallah, Assiut University:
evaluation
Additional relevant MeSH terms:
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Liver Cirrhosis
Long QT Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities