NCT05084846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

October 6, 2021

Last Update Submit

May 1, 2026

Conditions

InfluenzaCardiovascular Complication

Outcome Measures

Primary Outcomes (5)

  • Number of patients developing cardiovascular complications

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

    3 years

  • Number of patients developing in-hospital mortality

    3 years

  • Rate of cardiac dysfunction

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

    3 years

  • Prevalence of elevated biomarkers of infection/inflammation

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

    3 years

  • Rate of pulmonary embolisms diagnosed with CT thorax angiography

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients with laboratory confirmed influenza

You may qualify if:

  • All patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza
  • \> 18 years of age

You may not qualify if:

  • Persons not able to cooperate
  • Persons unable to understand and sign "informed consent"
  • Pregnancy
  • Persons simultaneously positive with COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herlev & Gentofte Hospital

Copenhagen, 2900, Denmark

Location

Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Research Director

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 20, 2021

Study Start

January 1, 2022

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

May 4, 2026

Record last verified: 2026-05

Locations

DK(2)