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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Serial KCCQ assessments delivered via chatbot

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Patients with heart failure who have been hospitalized for heart failure within the past six months1 intervention

Trial outcomes

Primary outcomes

1

Proportion of eligible patients who consent and enrol in the study

Recruitment rate

Time frame
6 and 12 months
2

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

Time frame
Baseline assesment
3

Proportion of those who stop the study

Dropout rate

Time frame
6 and 12 months
4

Proportion of completed KCCQ relative to those scheduled

Adherence to the protocol

Time frame
6 and 12 months

Secondary outcomes

1

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

Time frame
3, 6 and 12 months
2

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

Time frame
3, 6 and 12 months
3

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

Time frame
3, 6 and 12 months
4

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

Time frame
3, 6 and 12 months

Other outcomes

1

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

Composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.

Time frame
6 and 12 months
2

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

A composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death.

Time frame
6 and 12 months
3

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

Composite of WHF events to composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death

Time frame
6 and 12 months
4

Mean time from 5- and 10-point change KCCQ-OSS, KCCQ-CSS, and PLS to a composite of WHF events

A composite of WHF events (i) 1.5x increase in oral loop diuretic; ii) initiation of IV diuretic in outpatients' settings; iii) an emergency department visit or hospitalization for HF; or cardiovascular death/.

Time frame
6 and 12 months

Sponsors and contacts

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