March 31, 2026Journal of the American College of Cardiology1 citations
Interchangeability of the KCCQ-12 and KCCQ-23 Across >18,000 Participants Enrolled in 4 Large-Scale Trials of Heart Failure
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Key Result
The KCCQ-12 closely paralleled the KCCQ-23 in patients with HFmrEF/HFpEF, demonstrating strong baseline correlation (Spearman ρ = 0.987) and comparable prognostic discrimination.
Key Points
- This study aims to evaluate the interchangeability of the KCCQ-12 and KCCQ-23 in heart failure with mildly reduced or preserved ejection fraction.
- Conducted participant-level pooled analysis of 4 randomized clinical trials including patients with HFmrEF/HFpEF.
- Assessed concordance of KCCQ-12 and KCCQ-23 overall summary scores (OSS) and compared prognostic discrimination and treatment effects.
- Collected KCCQ-23 at baseline and follow-ups, derived KCCQ-12 scores from KCCQ-23 items.
- Baseline KCCQ-12 OSS was 64.1, and KCCQ-23 OSS was 65.5, with strong correlation (Spearman ρ = 0.987).
- Prognostic discrimination for cardiovascular death was similar (C index: 0.586 for KCCQ-12, 0.583 for KCCQ-23).
- Treatment effects on KCCQ-OSS were comparable across both instruments, with differences <1 point on a 0-100 scale.
Study Design
Type
Meta-Analysis (n=18,216)
Multicenter
Yes
Structured PICO
Does the KCCQ-12 provide comparable prognostic discrimination and treatment responsiveness to the KCCQ-23 in patients with HFmrEF/HFpEF?
P
Population
18,216 adults with HFmrEF/HFpEF enrolled in 4 large-scale trials (TOPCAT, PARAGON-HF, DELIVER, and FINEARTS-HF), mean age 72 ± 9 years, 46% female, 72% NYHA functional class II, mean LVEF 55 ± 8%.
I
Intervention
12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) overall summary score
C
Comparator
23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) overall summary score
O
Outcome
Concordance between KCCQ-12 OSS and KCCQ-23 OSS, prognostic discrimination for cardiovascular death and HF hospitalization, and treatment-related changespatient reported
The KCCQ-12 is highly concordant with the KCCQ-23 in patients with HFmrEF/HFpEF, supporting its use as a lower-burden alternative in clinical trials.
Main Result
Effect estimate: Spearman ρ = 0.987
Abstract
BACKGROUND: The 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) is formally qualified by the Food and Drug Administration as a valid patient-reported outcome measure for use in heart failure (HF) clinical trials. However, its length may increase respondent burden. The 12-item version (KCCQ-12) provides a more efficient alternative but was originally developed and validated in HF with reduced left ventricular ejection fraction (LVEF), and its performance relative to the KCCQ-23 has not been evaluated in HF with mildly reduced or preserved LVEF (HFmrEF/HFpEF). OBJECTIVE: The purpose of this study is to examine the interchangeability of KCCQ-12 and KCCQ-23 in patients with HFmrEF/HFpEF. METHODS: We conducted a participant-level pooled analysis of 4 randomized clinical trials (TOPCAT, PARAGON-HF, DELIVER, and FINEARTS-HF), including adults with HFmrEF/HFpEF. All trials collected the KCCQ-23 at baseline and follow-up visits. In this study, the KCCQ-12 overall summary scores (OSS) were derived from individual items of the KCCQ-23 OSS. Both scores ranged from 0 (worst) to 100 (best). We assessed concordance between KCCQ-12 OSS and KCCQ-23 OSS and compared prognostic discrimination and treatment-related changes. RESULTS: Of 18,216 participants (mean age: 72 ± 9 years; female: 46%; NYHA functional class II: 72%; mean LVEF: 55 ± 8%; median N-terminal pro-B-type natriuretic peptide levels: 987 IQR: 517-1,781 pg/mL), baseline KCCQ-23 OSS was 65.5 ± 21.4, and KCCQ-12 OSS was 64.1 ± 21.7. Baseline KCCQ-12 OSS strongly correlated with KCCQ-23 OSS (Spearman ρ = 0.987), consistent across major subgroups and follow-up visits (all Spearman ρ > 0.980). Prognostic discrimination for cardiovascular death and HF hospitalization was comparable (C index: 0.583 for KCCQ-23 vs 0.586 for KCCQ-12). Treatment effects of HF drugs on KCCQ-OSS were similar across the 2 instruments in each trial and at each time point (all the differences between KCCQ-23 and KCCQ-12 were <1 point on a 0-100 scale). CONCLUSIONS: In patients with HFmrEF/HFpEF, the KCCQ-12 closely parallels the KCCQ-23, demonstrating comparable prognostic performance and treatment responsiveness. These findings support the KCCQ-12 as a lower-burden alternative for use in HF clinical trials. (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist; NCT00094302; Prospective Comparison of Angiotensin Receptor-Neprilysin Inhibitor with Angiotensin Receptor Blocker Global Outcomes in HF with Preserved Ejection Fraction; NCT01920711; Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure; NCT03619213; Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure; NCT04435626).