Patient-reported KCCQ monitoring to detect early worsening of heart failure
Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
This project will try whether regular KCCQ questionnaires delivered by a chatbot can help detect early worsening in adults with chronic heart failure (NYHA II–III).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow, Non-US/Non-Canadian) |
| Trial ID | NCT07552142 on ClinicalTrials.gov |
What this trial studies
This prospective observational feasibility project will enroll 120 adults with chronic heart failure (NYHA II–III) and a recent HF hospitalization. Participants will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) via a chatbot every two weeks for 12 months while undergoing baseline, 3-, 6-, and 12-month in-person testing including transthoracic echocardiography, lung ultrasound, 6-minute walk test, and blood sampling. The study will link serial KCCQ score changes to markers of congestion and to clinical outcomes, including worsening heart failure events or cardiovascular death, and will measure the time from 5- and 10-point KCCQ changes to clinical events. Outcomes and feasibility metrics (acceptability, completion rates) will be collected at 6 and 12 months.
Who should consider this trial
Good fit: Adults (≥18) with chronic heart failure of any ejection fraction who are NYHA class II–III, had an HF hospitalization within the past six months, are currently free of congestion signs, are on stable oral loop diuretic doses if prescribed, and can use a smartphone and provide informed consent.
Not a fit: Patients with recent acute cardiac events or procedures within the last three months, ongoing clinical congestion, inability to use the chatbot (including significant cognitive impairment), or those unable to attend required in-person follow-up visits may not benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, this approach could allow earlier detection of worsening heart failure so clinicians can intervene sooner and potentially reduce hospitalizations and cardiovascular deaths.
How similar studies have performed: The KCCQ is a validated patient-reported instrument that has been linked to clinical outcomes in prior research, but frequent biweekly chatbot-delivered KCCQ monitoring for early detection of worsening heart failure is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Moscow, Non-US/Non-Canadian
- I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Non-US/Non-Canadian, Russia (Recruiting)
Study contacts
- Principal investigator: Anastasia Shchendrygina — I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Study coordinator: Anastasia Shchendrygina
- Email: a.shchendrygina@gmail.com
- Phone: +79262309207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.