Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening
Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
I.M. Sechenov First Moscow State Medical University
120 participants
Oct 1, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria11
- 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
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Interventions
Eligible patients will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 14-day intervals for a duration of 12 months. The KCCQ will be assessed using a chatbot delivered via Telegram Messenger, developed specifically for this study by the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07552142