The refer for echocardiogram, clinical decision rule and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in the diagnosis of heart failure

Not Applicable

Completed

• Conditions: Heart failure; Circulatory System

• Registration Number: ISRCTN17635379
• Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust (UK)

Brief Summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23110558 2017 results in https://pubmed.ncbi.nlm.nih.gov/28445025/ (added 19/02/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-21
• Study Completion: 2014-06-01
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

Current inclusion criteria as of 12/12/2011:
1. All patients 55 years of age or over presenting to their GP with new onset symptoms of breathlessness, lethargy or ankle oedema of over 48 hours duration, with no obvious recurrent, acute or self-limiting cause
2. Able to give informed consent

Previous inclusion criteria:
1. All patients 55 years of age or over presenting to their GP with new onset symptoms of breathlessness, lethargy or ankle oedema of over 48 hours duration, with no obvious acute and self-limiting cause
2. Able to give informed consent

Exclusion Criteria

Current exclusion criteria as of 12/12/2011
1. All patients with known pre-existing heart failure or left ventricular systolic dysfunction of any cause. However, patients with a pre-existing label of heart failure but without objective evidence (i.e. echocardiography) of this will not be excluded
2. Severe symptoms requiring urgent assessment or stabilisation (e.g. breathless at rest, hypotension, confusion)
3. Obvious clinically determined alternative diagnoses such as chest infection, exacerbation of chronic obstructive pulmonary disease or asthma
4. Recent acute coronary syndrome (within 60 days)
5. Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. malignancy, severe respiratory disease, renal diagnosis, mental health problem)
6. Unable to provide informed consent

Previous exclusion criteria
1. All patients with known pre-existing heart failure or left ventricular systolic dysfunction of any cause. However, patients with a pre-existing label of heart failure but without objective evidence (i.e. echocardiography) of this will not be excluded
2. Severe symptoms requiring urgent assessment or stabilisation (e.g. breathless at rest, hypotension, confusion)
3. Obvious clinically determined alternative diagnoses such as chest infection, exacerbation of chronic obstructive pulmonary disease or asthma
4. Recent acute coronary syndrome (within 60 days)
5. Major co-morbidity or other alternative diagnoses of no obvious acute and self-limiting cause (e.g. active malignancy, severe respiratory disease, renal diagnosis, severe psychiatric disease)
6. Unable to provide informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Test performance of the CDR, estimating the sensitivity and specificity, positive predictive value (PPV) and negative predictive value (NPV) of the CDR for diagnosis of HF in symptomatic patients presenting with shortness of breath, lethargy or ankle oedema of over 48 hours duration<br> 2. Test performance of the diagnostic accuracy of NT-proBNP for diagnosis of HF in symptomatic patients, including sensitivity, specificity, PPV and NPV<br> 3. Proportion of patients with left ventricular systolic dysfunction (LVSD) or not, (ejection fraction < 40%) and HF or not<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Combination of the CDR and NT-proBNP<br> 2. Modelling of CDR test performance and epidemiological data to ascertain the most cost-effective strategy in the diagnosis of HF in primary care, incorporating data on quality of life (EQ-5D and SF12 widely used questionnaires), clinical events and health care resource use<br> 3. Reliability of GP clinical judgment alone in diagnosing HF<br> 4. Reliability of individual clinical features<br> 5. Reliability of ECG interpretation<br> 6. Estimation of the best performing cut-offs for NT-proBNP to maximise diagnostic yield and for maximising cost-effective referrals<br> 7. Determine the use of variable echocardiographic markers of diastolic function in the diagnosis of HF with preserved ejection fraction<br>