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

Sponsor
University Hospital, Gentofte, Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05084846
Collaborator
(none)
300
Enrollment
2
Locations
38.9
Anticipated Duration (Months)
150
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influenza and the Heart: An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients developing cardiovascular complications [3 years]

      Including new-onset heart failure, worsening of current heart failure, acute myocardial infarction, and cardiac arrest

    2. Number of patients developing in-hospital mortality [3 years]

    3. Rate of cardiac dysfunction [3 years]

      Defined by impaired echocardiographic parameters and elevated cardiac biomarkers - NT - pro - BNP annd hs - TNT

    4. Prevalence of elevated biomarkers of infection/inflammation [3 years]

      Prevalence of elevated biomarkers of infection/inflammation and it association with cardiac dysfunction

    5. Rate of pulmonary embolisms diagnosed with CT thorax angiography [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herlev & Gentofte Hospital Copenhagen Denmark 2900
    2 Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital Hellerup Denmark 2900

    Sponsors and Collaborators

    • University Hospital, Gentofte, Copenhagen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tor Biering-Sørensen, Associate Professor and Research Director, University Hospital, Gentofte, Copenhagen
    ClinicalTrials.gov Identifier:
    NCT05084846
    Other Study ID Numbers:
    • H-21011835
    First Posted:
    Oct 20, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Influenza, Human

    Study Results

    No Results Posted as of Mar 9, 2022