Heart failure Circulatory System Heart failure
Conditions
Interventions
The general practitioner (GP) will have arranged for all patients to receive a chest x-ray when consenting patients for referral (as is usual practice). Within 7 days of referral, the research assessm
Sponsors
Oxford Radcliffe Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. Test performance of the diagnostic accuracy of NT-proBNP for diagnosis of HF in symptomatic patients, including sensitivity, specificity, PPV and NPV 3. Proportion of patients with left ventricular systolic dysfunction (LVSD) or not, (ejection fraction < 40%) and HF or not | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Combination of the CDR and NT-proBNP 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 3. Reliability of GP clinical judgment alone in diagnosing HF 4. Reliability of individual clinical features 5. Reliability of ECG interpretation 6. Estimation of the best performing cut-offs for NT-proBNP to maximise diagnostic yield and for maximising cost-effective referrals 7. Determine the use of variable echocardiographic markers of diastolic function in the diagnosis of HF with preserved ejection fraction | — |
Countries
United Kingdom
Outcome results
None listed