Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening
Recruiting · NCT07552142 · Observational (researchers observe without assigning treatment) · Lead sponsor: I.M. Sechenov First Moscow State Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Serial KCCQ assessments delivered via chatbot
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- I.M. Sechenov First Moscow State Medical University (Sechenov University) - Moscow, Non-US/Non-Canadian, Russia