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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02759445
Other study ID # C2-Strain
Secondary ID 14-110
Status Not yet recruiting
Phase N/A
First received November 24, 2015
Last updated April 29, 2016
Start date April 2016
Est. completion date October 2016

Study information

Verified date April 2016
Source RWTH Aachen University
Contact Michael Becker, Prof.
Phone 0049-241-8037137
Email mibecker@ukaachen.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. In general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. As only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap.

Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography will performed at baseline and at follow-up regarding conventional parameter [as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)] and myocardial deformation data [as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain].


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date October 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- healthy subjects who are not used to alcohol

- subjets who had an excessive alcohol Ingestion up to 12 hours before echocardiography

Exclusion Criteria:

- any heart disease

- subjects under 18 years

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
routine treatment
No intervention, only observation and describing

Locations

Country Name City State
Germany Department of Cardiology, RWTH Aachen University Hospital Aachen

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial Dysfunction by echocardiographic parameters Conventional echocardiographic parameters as left ventricular ejection fraction (measured in %) and volumes (measured in ml) and myocardial Deformation parameters as global and layer specific radial, longitudinal and circumferential strain (all measured in %) will be determined At 4 weeks follow-up No
Secondary Change from baseline in echocardiographic parameters These echocardiographic parameters will be determined at baseline and at 4 weeks follow up and the changes (assessed by percentage differences) will be given from baseline to follow up at 4 weeks No
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