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Active, not recruitingNCT05518396ProVa CoDE-HFUpdated Feb 3, 2026

Prospective Validation of the CoDE-HF Algorithm for the Diagnosis of Acute Heart Failure

An observational study in Acute Heart Failure and Diagnosis, sponsored by University of Edinburgh. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by University of Edinburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,808
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Acute Heart Failure
  • Diagnosis

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Keywords

  • Artificial Intelligence
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In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 3,808 is above the median of 210 across 573 observational studies indexed under Disease.

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Lead sponsor

University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All consecutive patients presenting to the Emergency Department with acute breathlessness will be included in this study

Eligibility criteria

Inclusion Criteria:

  • Patients presenting to the Emergency Department with acute breathlessness
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,808 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testCoDE-HF decision support tool

    We will assess the diagnostic performance of the CoDE-HF decision support tool

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What researchers measure

Primary outcomes

  1. Adjudicated diagnosis of acute heart failure

    Time frame: At index presentation

Secondary outcomes

  1. Subsequent hospitalisation with heart failure

    Time frame: 3 months

  2. All-cause death

    Time frame: 3 months

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Study locations

1 site
  • Centre for Cardiovascular Science, University of Edinburgh
    Edinburgh, EH16 4SB, United Kingdom
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided — IPD can be made available to researchers upon request to the principal investigator.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05518396
Lead sponsor
University of Edinburgh
Collaborators
NHS Lothian
Responsible party
Sponsor
First posted
Aug 26, 2022
Start date
Apr 25, 2021
Primary completion
Jun 1, 2024
Completion
Jun 30, 2028 (estimated)
Last update
Feb 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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