The Kansas City Cardiomyopathy Questionnaire measures heart failure symptoms, physical and social limitation and quality of life over the past two weeks, scored 0 to 100. It is one of the most important patient-reported outcomes in cardiovascular research.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Overall Summary
68
Clinical Summary
71
Change from baseline
+9
At a glance
In trials
Heart failure outcomes trials traditionally focus on cardiovascular death and hospitalisation. Those events matter, but so does how people feel and what they can do between them. The KCCQ captures that in a way that has been shown to track clinical status and predict outcomes, which is why it appears as a key secondary endpoint in many large heart failure trials, and as a primary endpoint in some trials of symptoms and function.
The KCCQ also works as an eligibility and enrichment tool: some trials enrol participants with KCCQ scores below a threshold to focus on people with meaningful symptoms. See EDC for heart failure trials for how it fits with events, biomarkers and walk tests.
The KCCQ-12 keeps the main domains and summary scores with fewer items, which helps when questionnaires are collected often or in older participants. Use the version your comparator data uses so results can be compared.
KCCQ · Week 12
Past 2 weeks · approved licensed version
Physical limitation
Item 1a
KCCQ1AScores
| Score | Built from | Range |
|---|---|---|
| Physical limitation | Limitation in everyday activities due to heart failure | 0 to 100 |
| Total symptom score | Symptom frequency and symptom burden | 0 to 100 |
| Quality of life | Enjoyment of life and satisfaction | 0 to 100 |
| Social limitation | Effect on hobbies, work and relationships | 0 to 100 |
| Clinical Summary Score | Physical limitation and total symptoms | 0 to 100 |
| Overall Summary Score | Physical, symptoms, quality of life and social | 0 to 100 |
Symptom stability and self-efficacy are reported separately and are not part of the summary scores. Score with the official scoring manual supplied under licence.
In Capture
Heart failure participants often find clinic visits tiring. The KCCQ can be completed at home on the participant's phone from a secure link, with windows and reminders around each scheduled time point. The form records the licence number, holder and expiry, and raw item values export with labels for scoring.
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 windows and reminders in the free sandbox.
Missing data
As in cancer trials, the participants with the worst health status are the most likely to miss questionnaires, particularly around hospital admissions and at the end of life. Remote completion, reminders and a clear process for recording why an assessment was missed reduce that bias. Death needs a defined handling rule in the analysis, because a missing KCCQ after death means something different from a missed questionnaire.
Some items allow "limited for other reasons or did not do the activity". These responses are treated as missing for that item under the scoring rules, so code them separately rather than mapping them onto the scale.
Before go-live
From the developer; details on the form.
Full KCCQ or KCCQ-12, matching comparator data.
Overall or Clinical Summary Score, pre-specified.
Separately from scale values.
Analysis rule for deaths and hospitalisations.
Supplied under the licence.
The Kansas City Cardiomyopathy Questionnaire, a patient-reported measure of heart failure symptoms, function, social limitation and quality of life.
Domain and summary scores are transformed to 0 to 100, with higher scores meaning better health status. Use the official scoring manual.
About 5 points is widely described as clinically meaningful.
A validated 12-item short form that keeps the main domains and summary scores.
It is copyrighted and licensed through its developer. Check the terms for your study.
Raw item values are stored with labels, and scores are derived in analysis using the scoring manual.
Licensed KCCQ with reminders and licence control. Free sandbox.