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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Serial KCCQ assessments delivered via chatbot
Other interventionEligible 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
Trial outcomes
Primary outcomes
Proportion of eligible patients who consent and enrol in the study
Recruitment rate
Median time to complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) delivered via chatbot
Proportion of those who stop the study
Dropout rate
Proportion of completed KCCQ relative to those scheduled
Adherence to the protocol
Secondary outcomes
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
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
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
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
Other outcomes
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.
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.
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
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/.
Sponsors and contacts
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