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Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening

Recruitingn/aAges 18 Years - anyAllI.M. Sechenov First Moscow State Medical Universiโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ300 pg/mL (sinus rhythm) or โ‰ฅ600 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
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What it tests

  • Serial KCCQ assessments delivered via chatbot
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Where

1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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