Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Proportion of eligible patients who consent and enrol in the study
Study Overview
Brief Summary
This observational feasibility study aims to assess (i) how practical and acceptable repeated KCCQ assessments are; (ii) the connection between changes over time in KCCQ scores and signs of congestion; and (iii) clinical outcomes, including worsening heart failure events or cardiovascular death (CVD), and the time between 5- and 10-point KCCQ changes and clinical events.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Established diagnosis of chronic HF with reduced, mildly reduced, or preserved ejection fraction, NYHA II-III
- •History of heart failure (HF) hospitalization within the last 6 months before enrollment, defined as the presence of dyspnea, elevated NT-proBNP ≥300 pg/mL (sinus rhythm) or ≥600 pg/mL (if AF), and 2 of the following: i. Rales on chest auscultation or signs of congestion on X-ray/CT scan; ii. Peripheral Oedema; iii. Loop diuretics IV at admission
- •Free of signs and symptoms of congestion, defined as JVP of <8 cm, with no orthopnea, pulmonary rales, and with trace peripheral edema or no edema.
- •Stable doses of oral loop diuretics, if prescribed
- •Ability to provide informed consent
Exclusion Criteria
- •Acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, ablation of atrial flutter/fibrillation, valve repair/replacement, implanted cardioverter defibrillator or urgent PCI within the last 3 months
- •Planned interventions, including major cardiac surgery (coronary artery bypass grafting, valve repair/replacement, ventricular assist device, cardiac transplantation), coronary revascularization, implantation of a cardiac device or ablation of atrial flutter/fibrillation during the study
- •Previous cardiac transplantation and candidates for heart transplantation
- •Complex congenital heart disease
- •Heart failure due to active myocarditis, pericardial constriction, known hypertrophic cardiomyopathy or cardiac amyloidosis, or uncorrected severe valvular heart disease
- •Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease
- •Cirrhosis, chronic active hepatitis, or other severe hepatic disease
- •Significant drug or alcohol abuse during the last year
- •Hemodialysis
- •Infective endocarditis
- •Any active cancer
Arms & Interventions
Patients with heart failure who have been hospitalized for heart failure within the past six months
Intervention: Serial KCCQ assessments delivered via chatbot (Other)
Outcomes
Primary Outcomes
Proportion of eligible patients who consent and enrol in the study
Time Frame: 6 and 12 months
Recruitment rate
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot
Time Frame: Baseline assesment
Proportion of those who stop the study
Time Frame: 6 and 12 months
Dropout rate
Proportion of completed KCCQ relative to those scheduled
Time Frame: 6 and 12 months
Adherence to the protocol
The mean rank of patient satisfaction with the intervention assessed by a survey
Time Frame: 6 and 12 months
Acceptability
Secondary Outcomes
- 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(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(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(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(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(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(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(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.(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(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(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(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(3, 6 and 12 months)
- The regression coefficient (β) relating the change in KCCQ-CSS to the change in PCWP assessed by echocardiography at 3, 6 and 12 months(3, 6 and 12 months)
- The regression coefficient (β) relating the change in KCCQ-СSS to the change in inferior vena cava IVC assessed by echocardiography at 3, 6 and 12 months(3, 6 and 12 months)
- The regression coefficient (β) relating the change in KCCQ-СSS to the change in total number of B-lines assessed by lung ultrasound at 3, 6 and 12 months(3, 6 and 12 months)
- The regression coefficient (β) relating the change in KCCQ-СSS and changes in NTproBNP at 3,6 and 12 months(3, 6 and 12 months)
- The regression coefficient (β) relating changes in KCCQ-СSS to changes in CA-125 at 3, 6, and 12 months.(3, 6 and 12 months)
- The regression coefficient (β) relating the change in KCCQ-СSS to the change in the 6-MW distance(3, 6 and 12 months)
Investigators
Anastasia Shchendrygina
Associate professor
I.M. Sechenov First Moscow State Medical University