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. 2019 Jun 19;21(7):932–942. doi: 10.1002/ejhf.1486
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.

a

Clinical Congestion Score.