- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084846
InFLUenza and the HEART An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection (FluHeart)
May 1, 2026 updated by: Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen
Influenza and the Heart: An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
"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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
241
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2900
- Herlev & Gentofte Hospital
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Hellerup, Denmark, 2900
- Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Hospitalized patients with laboratory confirmed influenza
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients developing cardiovascular complications
Time Frame: 3 years
|
Including new-onset heart failure, worsening of current heart failure, acute myocardial infarction, and cardiac arrest
|
3 years
|
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Number of patients developing in-hospital mortality
Time Frame: 3 years
|
3 years
|
|
|
Rate of cardiac dysfunction
Time Frame: 3 years
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Defined by impaired echocardiographic parameters and elevated cardiac biomarkers - NT - pro - BNP annd hs - TNT |
3 years
|
|
Prevalence of elevated biomarkers of infection/inflammation
Time Frame: 3 years
|
Prevalence of elevated biomarkers of infection/inflammation and it association with cardiac dysfunction
|
3 years
|
|
Rate of pulmonary embolisms diagnosed with CT thorax angiography
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
October 6, 2021
First Posted (Actual)
October 20, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
May 1, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-21011835
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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