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

NCT ID: NCT05518396

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3808 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-25
• Study Completion Date: 2028-06-30

Brief 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.

Conditions

Acute Heart Failure; Diagnosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CoDE-HF decision support tool

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients presenting to the Emergency Department with acute breathlessness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Cardiovascular Science, University of Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 35697365 (View on PubMed)

Other Identifiers

MRC/CIC8/79

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RE/18/5/34216

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DL-2021-003

Identifier Type: -

Identifier Source: org_study_id