Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening

The course of heart failure (HF) is characterized by episodes of worsening HF (WHF). These episodes increase the risk of hospitalization and death. Currently, reliable instruments for early identification of WHF are underdeveloped. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific, self-administered instrument designed to assess patient status. KCCQ allows detection of changes in clinical status in HF patients within a 14-day recall period and has the potential for early detection of WHF.

The study is an investigator-initiated, prospective, observational feasibility study aims to assess the (i) feasibility and acceptability of serial KCCQ assessment; (ii) the relationship between temporal changes in KCCQ scores and markers of congestion, as well as (iii) clinical outcome, a composite of worsening heart failure events or cardiovascular death (CVD), and the time from 5- and 10-point KCCQ changes to clinical events.

The study population will include 120 patients aged 18 years and above who meet the criteria. Eligible patients will undergo serial KCCQ assessments every 2 weeks for 12 months. Transthoracic echocardiography (TTE), lung ultrasound (LUS), 6-minute walk test (6MWT), and blood sampling will be performed at baseline, 3, 6, and 12 months. Outcomes will be collected at 6 and 12 months.

• The regression coefficient (β) relating the change in KCCQ-Total Symptoms Score (KCCQ-TSS) to the change in early mitral inflow velocity to early diastolic mitral annular velocity (E/e' ratio) assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in left atrial volume index (LAVI) assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in tricuspid regurgitation (TR) velocity assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in pulmonary capillary wedge pressure (PCWP) assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in inferior vena cava (IVC) assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS and changes in N-terminal pro-B-type Natriuretic Peptide (NTproBNP) at 3,6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS and changes in Cancer Antigen 125 (CA-125) at 3,6 and 12 months. [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-TSS to the change in the 6-Minute Walk (6MW) distance [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ Clinical Summary Score (KCCQ-CSS) to the change in E/e' ratio assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-CSS to the change in LAVI assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]
• The regression coefficient (β) relating the change in KCCQ-CSS to the change in TR velocity assessed by echocardiography at 3, 6 and 12 months [Time frame: 3, 6 and 12 months]