NCT03158701

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

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 14, 2017

Last Update Submit

May 17, 2017

Conditions

Keywords

evaluation

Outcome Measures

Primary Outcomes (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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All cirrhotic patients based on history and clinical diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
internal medicine resident,Assiut University hospital

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 18, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share