Trial period | Screening | Randomized treatment period | FU period | |||
---|---|---|---|---|---|---|
Visit (day of treatment) | 1 (−21 to −4) | 2 (1) |
3
(43 ± 7) |
4/End of treatment (85 ± 7) | Early DC on visit | FU visit (±7) or DC + 7 days |
Demographics | X | |||||
Vital signs | X | X | X | X | X | X |
HbA1c | X | X | X | |||
eGFR (CKD‐EPIcr formula) | X | X | X | X | X | X |
Safety lab | X | X | X | X | X | X |
ECG | X | X | X | |||
NT‐proBNP | X | X | X | X | X | |
6‐min walk test | X | X | X | X | X | |
Adverse events | X | X | X | X | X | X |
KCCQ | X | X | X | X | ||
CHQ‐SAS | X | X | X | X | ||
Clinical Congestion Scorea | X | X | X | X | ||
Patient Global Impression of Severity of heart failure symptoms | X | X | X | X | ||
Patient Global Impression of Severity of dyspnoea | X | X | X | X | ||
Patient Global Impression of Change in heart failure symptoms | X | X | X | |||
Patient Global Impression of Change in dyspnoea | X | X | X | |||
Clinician Global Impression of Severity of CHF | X | X | X | X | ||
Clinician Global Impression of Change in CHF severity | X | X | X | |||
NYHA classification | X | X | X | X | X | |
HCRU | X | X | X | X |
CHF, chronic heart failure; CHQ‐SAS, Chronic Heart Failure Questionnaire Self‐Administered Standardised format; CKD‐EPIcr, Chronic Kidney Disease‐Epidemiology Collaboration creatinine equation; DC, discontinuation; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; FU, follow‐up; HbA1c, glycated haemoglobin; HRCU, health care resource utilisation; KCCQ, Kansas City Cardiomyopathy Questionnaire; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; NYHA, New York Heart Association.
Patient's congestion will be assessed using a clinician‐based outcome assessment of orthopnoea, fatigue, jugular venous distention (as assessed by the investigator), and oedema. Each category will be assessed through a four‐measure questionnaire that will be further converted to a standardised 4‐point scale ranging from 0 to 3 as shown.
Clinical Congestion Score.