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Trial · NCT01644331

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDyspnea Improvement Measured by Likert Scale at 8 and 24 Hours8 and 24 hours
The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.
SecondaryRenal Function0, 24, 48 and 72 hoursChange in Serum creatinine from baseline to 24, 48 and 72 hours
SecondaryWeight Loss0, 24, 48, and 72 hoursChange in body weight from baseline to 24, 48, and 72 hours
SecondaryFluid Loss0, 24, 48, and 72 hoursChange from baseline fluid balance at 24, 48, and 72 hours
SecondaryDyspnea Likert48 and 72 hoursNumber of patients that experience moderate or greater improvement (patient reported) in dyspnea by 7 point Likert scale at 48 and 72 hours
SecondaryHospital Stay7 daysTotal days spent in hospital from baseline until discharge or death
SecondaryWorsening or Persistent Heart Failure or Death72 hrsNumber of patients with worsening heart failure or death
SecondaryOver-diuresis72 hoursclinical evidence of volume depletion requiring intervention other than holding diuretics during the 72 hours after randomization
SecondarySerum Sodium0, 24, 48, and 72 hoursChange in serum sodium from baseline to 24, 48, and 72 hours
SecondaryDyspnea 11 Point NRS0, 24, 48, and 72 hoursChange in NRS for assessment of dyspnea from baseline to 24, 48, and 72 hours (scale ranges from 0-No difficulty breathing to 10-Difficulty as bad as you can imagine)
SecondaryFreedom From Congestion24, 48, and 72 hoursJugular Venous Pressure (JVP) \< 8 cm, no orthopnea, trace peripheral edema or less, and will be assessed at 24, 48, and 72 hours
SecondaryDevelopment of Worsening Renal Function72 hoursincrease in serum creatinine ≥ 0.3mg/dl from randomization at any time point during 72 hours after randomization
SecondaryDays Hospitalized or Deceased30 daysTotal days hospitalized or deceased during the 30 days after randomization
SecondaryAll Cause Death or Rehospitalization30 daysAll cause death or rehospitalization (to include unscheduled clinic visits or ED visits) at 30 days (Kaplan-Meier and 95% confidence interval)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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