Acute Heart FailureProVa CoDE-HFNCT05518396
Prospective Validation of the CoDE-HF Algorithm for the Diagnosis of Acute Heart Failure
An observational study of Acute Heart Failure and Diagnosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Acute heart failure is a life-threatening condition where the heart is suddenly unable to pump blood around the body. It can be challenging to diagnose because the symptoms often mimic other conditions. Previous studies have showed that delays in making the correct diagnosis result in worse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Diagnosis
- What is being tested?
- CoDE-HF decision support tool
- How many people
- 3,808 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2021to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients presenting to the Emergency Department with acute breathlessness will be included in this study
Who may be able to join
- Patients presenting to the Emergency Department with acute breathlessness
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Science, University of Edinburgh
Edinburgh, EH16 4SB
About this study
Acute heart failure is a life-threatening condition where the heart is suddenly unable to pump blood around the body. It can be challenging to diagnose because the symptoms often mimic other conditions. Previous studies have showed that delays in making the correct diagnosis result in worse outcomes. We therefore developed a decision-support tool called CoDE-HF that uses a computer algorithm to combine levels of a blood test called NT-proBNP with patient factors to calculate the probability of acute heart failure for an individual.
In this project, we wish to evaluate the performance of CoDE-HF in approximately 2,000 patients attending the Emergency Department with suspected acute heart failure. We will store surplus material from their blood tests to measure NT-proBNP and link information from their electronic health records with other routinely collected medical information in regional and national databases in order to evaluate this algorithm.
- Conditions
- Acute Heart Failure, Diagnosis
- Being tested
- CoDE-HF decision support tool
- Keywords
- Artificial Intelligence
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoDE-HF decision support toolDiagnostic test
We will assess the diagnostic performance of the CoDE-HF decision support tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated diagnosis of acute heart failure
Measured: At index presentation
Secondary outcomes (2)
Subsequent hospitalisation with heart failure
Measured: 3 months
All-cause death
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start25 Apr 2021
- Primary completion1 Jun 2024
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- 3,808 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518396
- Sponsor's protocol ID
- DL-2021-003
- Other IDs
- MRC/CIC8/79, RE/18/5/34216
- Acronym
- ProVa CoDE-HF
- Status last verified
- Jan 2026
- First submitted
- 24 Aug 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be made available to researchers upon request to the principal investigator.
Publications
Lee KK, Doudesis D, Anwar M, Astengo F, Chenevier-Gobeaux C, Claessens YE, Wussler D, Kozhuharov N, Strebel I, Sabti Z, deFilippi C, Seliger S, Moe G, Fernando C, Bayes-Genis A, van Kimmenade RRJ, Pinto Y, Gaggin HK, Wiemer JC, Mockel M, Rutten JHW, van den Meiracker AH, Gargani L, Pugliese NR, Pemberton C, Ibrahim I, Gegenhuber A, Mueller T, Neumaier M, Behnes M, Akin I, Bombelli M, Grassi G, Nazerian P, Albano G, Bahrmann P, Newby DE, Japp AG, Tsanas A, Shah ASV, Richards AM, McMurray JJV, Mueller C, Januzzi JL, Mills NL; CoDE-HF investigators. Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta-analysis, and modelling study. BMJ. 2022 Jun 13;377:e068424. doi: 10.1136/bmj-2021-068424.
PubMed 35697365
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of the CoDE-HF Algorithm for the Diagnosis of Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05518396
- Acronym / sponsor ID
- ProVa CoDE-HF / DL-2021-003
- Conditions
- Acute Heart Failure, Diagnosis
- Keywords
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,808 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2022 (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.
Acute heart failure is a life-threatening condition where the heart is suddenly unable to pump blood around the body. It can be challenging to diagnose because the symptoms often mimic other conditions. Previous studies have showed that delays in making the correct diagnosis result in worse outcomes. We therefore developed a decision-support tool called CoDE-HF that uses a computer algorithm to combine levels of a blood test called NT-proBNP with patient factors to calculate the probability of acute heart failure for an individual.
In this project, we wish to evaluate the performance of CoDE-HF in approximately 2,000 patients attending the Emergency Department with suspected acute heart failure. We will store surplus material from their blood tests to measure NT-proBNP and link information from their electronic health records with other routinely collected medical information in regional and national databases in order to evaluate this algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting to the Emergency Department with acute breathlessness will be included in this study
Key inclusion criteria (1 listed)
- Patients presenting to the Emergency Department with acute breathlessness
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoDE-HF decision support toolWe will assess the diagnostic performance of the CoDE-HF decision support tool | Diagnostic test | – |
Primary outcome
Adjudicated diagnosis of acute heart failure
Time frame: At index presentation
2 secondary outcomes
Subsequent hospitalisation with heart failure
Time frame: 3 months
All-cause death
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 35697365Lee KK, Doudesis D, Anwar M, Astengo F, Chenevier-Gobeaux C, Claessens YE, Wussler D, Kozhuharov N, Strebel I, Sabti Z, deFilippi C, Seliger S, Moe G, Fernando C, Bayes-Genis A, van Kimmenade RRJ, Pinto Y, Gaggin HK, Wiemer JC, Mockel M, Rutten JHW, van den Meiracker AH, Gargani L, Pugliese NR, Pemberton C, Ibrahim I, Gegenhuber A, Mueller T, Neumaier M, Behnes M, Akin I, Bombelli M, Grassi G, Nazerian P, Albano G, Bahrmann P, Newby DE, Japp AG, Tsanas A, Shah ASV, Richards AM, McMurray JJV, Mueller C, Januzzi JL, Mills NL; CoDE-HF investigators. Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta-analysis, and modelling study. BMJ. 2022 Jun 13;377:e068424. doi: 10.1136/bmj-2021-068424.
- Individual participant dataSharing planned: Undecided. IPD can be made available to researchers upon request to the principal investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Diagnosis, run by University of Edinburgh at 1 site in United Kingdom.
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 1 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adjudicated diagnosis of acute heart failure (time frame: At index presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518396, which also lists 1 linked publication.
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 3 Feb 2026.