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

Acute Heart Failure Clinical Trial

— ProVa CoDE-HF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05518396
• Other study ID #: DL-2021-003
• Secondary ID: MRC/CIC8/79RE/18
• Status: Active, not recruiting
• Start date: April 25, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2351
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting to the Emergency Department with acute breathlessness

Related Conditions & MeSH terms

• Acute Heart Failure
• Diagnosis
• Disease
• Heart Failure

Intervention

Diagnostic Test:
• CoDE-HF decision support tool
We will assess the diagnostic performance of the CoDE-HF decision support tool

Locations

Country	Name	City	State
United Kingdom	Centre for Cardiovascular Science, University of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated diagnosis of acute heart failure		At index presentation
Secondary	Subsequent hospitalisation with heart failure		3 months
Secondary	All-cause death		3 months