NCT07552142Recruiting
Patient-Reported Health Status Assessment Using the KCCQ for Early Detection of Heart Failure Worsening
Patient-Reported Health Status Assessment Using the Kansas City Cardiomyopathy Questionnaire for Early Detection of Heart Failure Worsening
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 10 Apr 2026
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Diseases
- Heart failure
- NCT number
- NCT07552142
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Oct 2025 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cardiac transplantation and candidates for heart transplantation
- Significant drug or alcohol abuse during the last year
Other illness
- 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
- 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
- Any active cancer
Other
- Hemodialysis
- Infective endocarditis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| I.M. Sechenov First Moscow State Medical University (Sechenov University) Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.