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. Author manuscript; available in PMC: 2013 Mar 1.
Published in final edited form as: J Card Fail. 2012 Feb 2;18(3):176–182. doi: 10.1016/j.cardfail.2011.12.009

Table 1.

Secondary Objectives of CARRESS-HF

  1. Bivariate response of change in creatinine and change in weight from randomization to days 1 through 3 and day 7 (or discharge).

  2. Changes in serum electrolytes and renal function, including creatinine, blood urea nitrogen, estimated glomerular filtration rate, and cystatin C, at multiple time points.*

  3. Changes in volume status, including significant weight loss (≥3.0 kg), net fluid loss, B-type natriuretic peptide, and clinical decongestion (defined as pulmonary wedge pressure < 18 cm [if available], jugular venous pressure or central venous pressure < 8 cm [if available], no more than trace peripheral edema, and the absence of orthopnea), at multiple time points.*

  4. Treatment failure defined as death, worsening/persistent heart failure, need for dialysis, crossover from stepped pharmacologic care to ultrafiltration, or the occurrence of a serious adverse event during the first 7 days after randomization.

  5. Changes in symptoms assessed using global and dyspnea visual analog scores assessed at 96 hours and on day 7 (or discharge).

  6. Number of days in hospital assessed from randomization to discharge.

  7. Length of index hospitalization, heart failure rehospitalizations, days alive outside the hospital, and unscheduled clinic and emergency department visits during the 60-day follow-up interval.

  8. Diuretic doses before hospitalization and on day 7 (or discharge), 30 days, and 60 days.

  9. Adverse events, including device-related adverse events.

*

Assessments at multiple time points include the following: Change in electrolytes will be assessed at 96 hours and 1 week; change in creatinine, blood urea nitrogen, and estimated glomerular filtration rate will be assessed at 96 hours, 1 week, and 30 and 60 days; change in C-reactive protein will be assessed at 96 hours, 1 week, and 60 days; change in weight will be assessed daily until discharge or day 7, whichever comes first, and 30 and 60 days; change in B-type natriuretic peptide will be assessed at 96 hours, 1 week, and 60 days; clinical decongestion will be assessed at 96 hours, 1 week, and 30 and 60 days.