Actively Recruiting

Age: 18Years +
All Genders
NCT07552142

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

Led by I.M. Sechenov First Moscow State Medical University · Updated on 2026-04-27

120

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established diagnosis of chronic heart failure with reduced, mildly reduced, or preserved ejection fraction, NYHA class II-III
  • History of heart failure hospitalization within the last 6 months, including symptoms such as dyspnea, elevated NT-proBNP levels, and signs of congestion
  • Free of signs and symptoms of congestion, including low jugular venous pressure, no orthopnea, no pulmonary rales, and minimal or no peripheral edema
  • Stable doses of oral loop diuretics if prescribed
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Recent acute coronary syndrome, cardiac surgery, pulmonary embolism, cerebrovascular accident, or atrial flutter/fibrillation ablation within the last 3 months
  • Planned major cardiac interventions or device implantations during the study period
  • Previous heart transplantation or candidacy for heart transplantation
  • Complex congenital heart disease
  • Heart failure caused by active myocarditis, pericardial constriction, hypertrophic cardiomyopathy, cardiac amyloidosis, or uncorrected severe valvular heart disease
  • Primary pulmonary hypertension, chronic pulmonary embolism, or severe pulmonary disease
  • Severe liver disease such as cirrhosis or chronic active hepatitis
  • Significant drug or alcohol abuse within the last year
  • Receiving hemodialysis
  • Infective endocarditis
  • Any active cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Non-US/Non-Canadian, Russia

Actively Recruiting

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Research Team

A

Anastasia Shchendrygina

CONTACT

S

Svetlana Rachina

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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