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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03158701
Other study ID # assiut university 7000
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 14, 2017
Last updated May 17, 2017
Start date June 1, 2017
Est. completion date June 1, 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
one year
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