Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening
Recruiting
Observational Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
120 (estimated)
Sponsor
I.M. Sechenov First Moscow State Medical University · Other
Who this trial is looking for
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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.
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Eligibility 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 rh…
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
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