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What would it mean for your HFrEF patients to feel better?

PARADIGM-HF evaluated patients' overall quality of life (QoL) using the KCCQ-23, which includes these domains1,2:

  • Physical limitation

  • Symptom frequency

  • Symptom burden

  • Symptom stability

  • Self-efficacy

  • Social limitation

  • QoL

Each domain is scored on a scale of 0-100; higher scores indicate better health status.

The KCCQ-23 Clinical Summary score (CS) represents the average of the symptom (frequency and burden) and physical limitation domains.1,2 

Analysis included all patients with at least 1 KCCQ data up to month 8. For patients who died, the worst score (0) was imputed for the CS at all subsequent scheduled visits.

KCCQ-23 results

Change in the KCCQ-23 CS from baseline to 8 months was a prespecified secondary outcome in PARADIGM-HF.1,3

Mean change in KCCQ-23 CS at 8-month, double-blind period: ENTRESTO -2.99 (n=4187), enalapril -4.63 (n=4212). Clinically meaningful difference established as 5 points.3 

PARADIGM-HF: KCCQ-23 analysis limitations2

  • Baseline KCCQ-23 CS in the overall PARADIGM-HF population was assessed at randomization. This may have resulted in higher baseline scores due to treatment during the run-in phase. Limited data exist assessing clinical meaningfulness of change scores in patients with relatively good baseline perceptions of HRQoL

  • Statistical analysis suggests that the difference between ENTRESTO and enalapril treatment arms may have been driven in part by the treatment effect on HF hospitalizations

KCCQ-23 tool limitations1,2

  • 2-week recall period

  • Missing scores in physical limitation domain due to conditions other than HF

*In PARAGON-HF, defined as LVEF ≥45% with structural heart disease (LAE or LVH); median LVEF was 57%. LVEF is a variable measure and the normal range can vary.4

Definitions
ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; HRQoL, health-related quality of life; KCCQ-23, Kansas City Cardiomyopathy Questionnaire-23; NYHA, New York Heart Association.

References
1. Spertus JA, Jones PG. Development and validation of a short version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015;8(5):469-476. doi:10.1161/CIRCOUTCOMES.115.001958
2. Lewis EF, Claggett BL, McMurray JJV, et al. Health-related quality of life outcomes in PARADIGM-HF. Circ Heart Fail. 2017;10(8):e003430. doi:10.1161/CIRCHEARTFAILURE.116.003430
3. McMurray JJV, Packer M, Desai AS, et al; for the PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. doi:10.1056/NEJMoa1409077
4. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.