Table 2. WP2b clinical and behavioural variables
Physical characteristics AnthropHeight in centimetres, weight in kilograms, BMI kg/m2
VitalsBlood pressure (mmHg)
Respiratory rate (breaths per minute)
Pulse rate (beats per minute)
Past medical history N/APast and current medical problems and medications will be extracted from primary and secondary care records
Clinical events HESHospital Episode Statistics (date, length of time and index reason for hospitalisations, accident and emergency attendances, and outpatient appointments)
Heart function ECG12-lead ECG
EchoDetailed echocardiogram with high-quality diastolic and right ventricle functional assessment
Arterial stiffness a PWVA validated reproducible technique to investigate the clinical relevance of vascular and arterial stiffness36
Peripheral oedema N/A Clinical assessment of oedema including level (extent) and presence or absence of pitting
Breathlessness and fatigue mBORGValid, reliable measure of the intensity of the sensation of breathlessness and fatigue37
Frailty CFSA validated measure of frailty based on clinical judgment38
SHARE-FIA validated automated instrument that generates a pre-calculated, population-representative, and sex-specific frailty class39
eFIeFI uses routine medical record data to identify older people with mild, moderate, and severe frailty and will be abstracted from primary care records40
Comorbidity CCIWidely used validated measure of 1-year mortality risk and burden of disease41
Cognition MoCAThe MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment42
Physical functioning and activity 6MWTA standardised submaximal test of aerobic capacity, validated in multiple populations and conditions43
GSGait speed measured over 10 metres, a valid objective measure of functional mobility44
AccelerObjective measure of activity obtained via Axivity AX3 wrist-worn triaxial accelerometer programmed to start at 19:00 hours on the day of the baseline visit (to prevent capturing of protocol forced activity) and capture triaxial acceleration data over a 7-day period at 100 Hz with a dynamic range of +–8 g45
Laboratory testing BiochemSerum sodium, potassium, creatinine, urea, estimated GFR, random plasma glucose
HaemWhite and red blood cell count, haemoglobin, haematocrit, mean cell volume, mean cell haemoglobin, red cell distribution width, platelet count, mean platelet volume, neutrophil, lymphocyte, monocyte, eosinophil, basophil count
Biomarkers HbA1cAn indicator of the average blood glucose concentrations over the preceding ~2  months.
NPNatriuretic peptides (NT-proBNP), a diagnostic marker in patients with heart failure
Dietary intake a InterviewOne 24-hour dietary recalled will be collected to ascertain over or undernutrition in HFpEF patients
Anxiety and depression HADSHADS is a widely used questionnaire that screens for the separate dimensions of anxiety and depression and has been validated in multiple populations32
HF QoL KCCQKCCQ is a valid, reliable and responsive health status measure for patients with chronic heart failure that has been shown to have clinically meaningful changes33
HF self-care EHFScBQA valid, reliable and practical scale to measure the self-reported self-care behaviour of heart failure patients.34
HF symptoms SSQ-HFValid and reliable score to assess physical symptoms in patients with heart failure.35
Health-related QoL EQ-5DThe EQ-5D is a widely used five-domain patient-based generic questionnaire for self-perceived health assessment. It describes health-related quality of life and has been extensively validated.
  • 6MWT = 6-minute walk test. Acceler = accelerometry. Anthrop = anthropometry. Biochem = biochemistry. BMI = body mass index. CCI = Charlson comorbidity index. CFS = clinical frailty scale. ECG = electrocardiogram. Echo = echocardiogram. eFI = electronic frailty index. eGFR = estimated glomular filtration rate. EHFScBQ = European heart failure self-care behaviours questionnaire. EQ-5D = the EuroQol 5D questionnaire. GS = gait speed. HADS = hospital anxiety and depression score. Haem = haematology. HbA1c = glycated haemoglobin A1c. HES = hospital episode statistics. KCCQ = Kansas City cardiomyopathy questionnaire. mBORG = modified BORG. MoCA = Montreal cognitive assessment. N/A = not applicable. NP = natriuretic peptides. PWV = pulse wave velocity. QoL = quality of life. SHARE-FI = SHARE frailty instrument. SSQ-HF = symptom status questionnaire — heart failure.

  • aIndicates single site sub-study.