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

NCT07552142 | Recruiting

• 1 other identifier: 10-25
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Heart Failure

Keywords

Kansas City Cardiomyopathy Questionnaire; Heart failure; worsening heart failure; monitoring; Cardiovascular Diseases; Heart Diseases; Congestion

Outcome Measures

Primary Outcomes (5)

• Proportion of eligible patients who consent and enrol in the study

  Recruitment rate

  6 and 12 months

• Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot

  Baseline assesment

• Proportion of those who stop the study

  Dropout rate

  6 and 12 months

• Proportion of completed KCCQ relative to those scheduled

  Adherence to the protocol

  6 and 12 months

• The mean rank of patient satisfaction with the intervention assessed by a survey

  Acceptability

  6 and 12 months

Secondary Outcomes (18)

• The regression coefficient (β) relating the change in KCCQ-Total Symptoms Score (KCCQ-TSS) to the change in early mitral inflow velocity to early diastolic mitral annular velocity (E/e' ratio) assessed by echocardiography at 3, 6 and 12 months

  3, 6 and 12 months

• The regression coefficient (β) relating the change in KCCQ-TSS to the change in left atrial volume index (LAVI) assessed by echocardiography at 3, 6 and 12 months

  3, 6 and 12 months

• The regression coefficient (β) relating the change in KCCQ-TSS to the change in tricuspid regurgitation (TR) velocity assessed by echocardiography at 3, 6 and 12 months

  3, 6 and 12 months

• The regression coefficient (β) relating the change in KCCQ-TSS to the change in pulmonary capillary wedge pressure (PCWP) assessed by echocardiography at 3, 6 and 12 months

  3, 6 and 12 months

• The regression coefficient (β) relating the change in KCCQ-TSS to the change in inferior vena cava (IVC) assessed by echocardiography at 3, 6 and 12 months

  3, 6 and 12 months

Other Outcomes (4)

• Temporal changes in KCCQ-TSS to a composite of worsening heart failure (WHF) events and their components

  6 and 12 months

• Temporal changes in KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events and their components

  6 and 12 months

• Mean time from 5- and 10-point change in KCCQ-TSS to a composite WHF events

  6 and 12 months

Study Arms (1)

Patients with heart failure who have been hospitalized for heart failure within the past six months

Other: Serial KCCQ assessments delivered via chatbot

Interventions

Serial KCCQ assessments delivered via chatbot OTHER

Eligible patients will complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 14-day intervals for a duration of 12 months. The KCCQ will be assessed using a chatbot delivered via Telegram Messenger, developed specifically for this study by the research team.

Patients with heart failure who have been hospitalized for heart failure within the past six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged ≥ 18 years with an established diagnosis of heart falure who were admitted to the center the last 6 months will be candidates for screening. They will be enrolled if they meet the inclusion criteria and none of the exclusion criteria are present. If hospitalized at the time of screening, the patient will be enrolled in the study after stabilization and when free of signs and symptoms of congestion (defined as jugular venous pressure of \<8 cm, with no pulmonary rales, orthopnea, and with trace peripheral edema or no edema) and is stable on a maintenance dose of oral diuretics for 48 hours.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, Non-US/Non-Canadian, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Officials

• Anastasia Shchendrygina

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Shchendrygina

CONTACT

+79262309207; a.shchendrygina@gmail.com

Svetlana Rachina

CONTACT

rachina_s_a@staff.sechenov.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)