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NCT05084846 Clinical Trial

InFLUenza and the HEART An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection

Influenza Clinical Trial

— FluHeart  

Official title:
Influenza and the Heart: An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05084846
Other study ID # H-21011835
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date March 31, 2025

Study information
Verified date June 2023
Source University Hospital, Gentofte, Copenhagen
Contact Kristoffer G Skaarup, MD
Phone 004542451250
Email KRISTOFFERSKAARUP@HOTMAIL.COM
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

"Influenza and the Heart: An investigation into the acute and lasting cardiac effects of influenza infection" the investigators aim to assess the mechanisms for cardiovascular disease in patients suffering an acute influenza infection. The project will be carried out by creating a prospective clinical cohort study of consecutive patients hospitalized at Herlev & Gentofte University Hospital with a laboratory confirmed influenza.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date March 31, 2025
Est. primary completion date April 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients hospitalized at Herlev & Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza - > 18 years of age Exclusion Criteria: - Persons not able to cooperate - Persons unable to understand and sign "informed consent" - Pregnancy - Persons simultaneously positive with COVID-19

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Herlev & Gentofte Hospital Copenhagen
Denmark Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital Hellerup

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients developing cardiovascular complications Including new-onset heart failure, worsening of current heart failure, acute myocardial infarction, and cardiac arrest 3 years
Primary Number of patients developing in-hospital mortality 3 years
Primary Rate of cardiac dysfunction Defined by impaired echocardiographic parameters and elevated cardiac biomarkers - NT
- pro
- BNP annd hs
- TNT		 3 years
Primary Prevalence of elevated biomarkers of infection/inflammation Prevalence of elevated biomarkers of infection/inflammation and it association with cardiac dysfunction 3 years
Primary Rate of pulmonary embolisms diagnosed with CT thorax angiography 3 years
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