InfluenzaFluHeartNCT05084846
InFLUenza and the HEART An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
An observational study of Influenza and Cardiovascular Complication, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza, Cardiovascular Complication
- How many people
- 241 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jan 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Hospitalized patients with laboratory confirmed influenza
Who may be able to join
- All patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza
- > 18 years of age
Who cannot join
- Persons not able to cooperate
- Persons unable to understand and sign "informed consent"
- Pregnancy
- Persons simultaneously positive with COVID-19
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev & Gentofte Hospital
Copenhagen, 2900
Cardiovascular Non-Invasive Imaging Research Laboratory, department of Cardiology, Herlev & Gentofte Hospital
Hellerup, 2900
About this study
Official title: 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.
- Conditions
- Influenza, Cardiovascular Complication
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients developing cardiovascular complications
Including new-onset heart failure, worsening of current heart failure, acute myocardial infarction, and cardiac arrest
Measured: 3 years
Number of patients developing in-hospital mortality
Measured: 3 years
Rate of cardiac dysfunction
Defined by impaired echocardiographic parameters and elevated cardiac biomarkers - NT
- pro
- BNP annd hs
- TNT
Measured: 3 years
Prevalence of elevated biomarkers of infection/inflammation
Prevalence of elevated biomarkers of infection/inflammation and it association with cardiac dysfunction
Measured: 3 years
Rate of pulmonary embolisms diagnosed with CT thorax angiography
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Jan 2022
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Biering-Sørensen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084846
- Sponsor's protocol ID
- H-21011835
- Acronym
- FluHeart
- Status last verified
- May 2026
- First submitted
- 6 Oct 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza and the Heart: An Investigation Into the Acute and Lasting Cardiac Effects of Influenza Infection
- ClinicalTrials.gov ID
- NCT05084846
- Acronym / sponsor ID
- FluHeart / H-21011835
- Conditions
- Influenza, Cardiovascular Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with laboratory confirmed influenza
Key inclusion criteria (2 listed)
- All patients hospitalized at Herlev \& Gentofte University Hospital with a laboratory-confirmed diagnosis of influenza
- > 18 years of age
Key exclusion criteria (4 listed)
- Persons not able to cooperate
- Persons unable to understand and sign "informed consent"
- Pregnancy
- Persons simultaneously positive with COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Number of patients developing in-hospital mortality
Time frame: 3 years
Rate of cardiac dysfunction
Time frame: 3 years
Defined by impaired echocardiographic parameters and elevated cardiac biomarkers - NT - pro - BNP annd hs - TNT
Prevalence of elevated biomarkers of infection/inflammation
Time frame: 3 years
Prevalence of elevated biomarkers of infection/inflammation and it association with cardiac dysfunction
Rate of pulmonary embolisms diagnosed with CT thorax angiography
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Cardiovascular Complication, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients developing cardiovascular complications (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.