Heart failure trials count hospitalisations and deaths, measure symptoms and function, and depend on eligibility criteria built on ejection fraction, natriuretic peptides and kidney function. Capture structures all of it in one study.
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Event type
HFETYPEAdmission date
HFESTDTCIntravenous diuretics given
HFEIVDSource documents collected for review
HFESRCWhat matters in heart failure trials
Study design
Heart failure outcome trials live or die on event capture. A site reports a hospitalisation as an adverse event; someone must recognise it as a potential endpoint, collect the discharge summary and other source documents, and send a structured package to the clinical events committee. When those steps depend on memory, events are missed or arrive incomplete.
Structured event forms help: a dedicated heart failure event form with the facts the definition depends on (admission, length of stay, intravenous diuretics or other treatment, signs and symptoms), and a clear link from the adverse event to the event form. Keep the investigator-reported event and the committee's adjudicated result as separate variables, so the analysis uses the adjudicated outcome and the difference can be reviewed.
Many recent trials also count urgent visits with intravenous diuretics or outpatient intensification of oral diuretics. If your endpoint includes them, give them their own event type and the fields that define them.
Site records hospitalisation
Serious AE and heart failure event form
Source documents collected
Discharge summary and key results
Events committee review
Per the adjudication charter
Adjudicated result recorded
Kept separate from site-reported event
Eligibility
Calculated fields show eGFR (CKD-EPI 2021), creatinine clearance (Cockcroft-Gault), BMI and other derived values read-only during entry, so the site sees immediately whether a participant meets kidney function criteria. Custom-value edit checks raise a query when ejection fraction or NT-proBNP values fall outside the protocol thresholds.
BMI (Body Mass Index)
Auto-derivedHeight (cm)
172
Weight (kg)
68.5
Result
23.2 kg/m²
Reference: WHO · shown read-only during data entry
Patient-reported outcomes
Participants with heart failure often find extra clinic visits tiring. The KCCQ and other questionnaires can be completed at home on the participant's phone from a secure link, with windows and reminders around each time point, and licence details recorded on the form.
When due
18:00
Your evening diary is open
Next day
18:00
Reminder: your diary is still open
Final notice
21:30
Last chance before the window closes
Quiet hours
22:00 to 08:00 in the participant's time zone
Stops
As soon as the task is completed
Set up calculated eGFR and heart failure event forms in the free sandbox.
Endpoints
| Endpoint | Data needed |
|---|---|
| CV death or HF hospitalisation (time to first event) | Event forms, death forms with cause, adjudicated results, dates |
| Total HF events | Every event, including recurrent hospitalisations and urgent visits |
| Hierarchical composite (win ratio) | Death, events and KCCQ change, with the order defined in the analysis plan |
| KCCQ change | Questionnaires at baseline and follow-up time points |
| 6-minute walk distance | Standardised walk tests at visits |
| NT-proBNP change | Central or local lab values with dates and units |
Safety
Many heart failure drugs affect kidney function, potassium or blood pressure, and participants often take several such drugs already. Safety monitoring therefore focuses on repeated lab values and vital signs, with thresholds that trigger dose adjustments. Range edit checks on potassium, creatinine and blood pressure raise queries at entry so values outside expected ranges are confirmed quickly.
Background therapy also matters for interpretation: record guideline-directed medications and dose changes on the concomitant medications form, because changes in background therapy during the trial can affect outcomes.
Study build
HF hospitalisation, urgent visit and death forms with defining fields.
Source document collection and separate adjudicated variables.
LVEF, NT-proBNP (including AF thresholds) and eGFR checks.
KCCQ at defined time points, completed at home.
Potassium, creatinine and blood pressure ranges.
Guideline-directed medications and dose changes recorded.
A composite of cardiovascular death or heart failure hospitalisation, total heart failure events, hierarchical composites, and health status measured by the KCCQ.
Capture structures event data and records adjudicated results as separate variables. The adjudication process itself follows your committee's charter.
Yes. eGFR (CKD-EPI 2021) and creatinine clearance (Cockcroft-Gault) are available as calculated fields shown during entry.
Yes, on their own phone from a secure link, with windows and reminders.
An analysis of a hierarchical composite endpoint that compares each participant in one arm with each in the other, starting with the most important outcome.
Yes, in the free sandbox with every feature.
Keep exploring
Events, eligibility and PROs in one study. Free sandbox.