Patient-reported KCCQ monitoring to detect early worsening of heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.