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Trial · NCT06898515

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryHierarchical composite/win-ratio1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment
PrimaryIncidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)initiation of randomized therapy through 72 hours following completion of randomized therapyKDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
SecondaryNet sodium lossper 24 hours at end of randomized therapy
SecondaryTime to discharge readinessthrough hospital discharge, an average of 5 daysTime from initiation of randomized therapy to when the participant becomes medically ready for discharge from a decompensated heart failure treatment standpoint
SecondaryTime on IV diuretic therapyrandomization through hospital discharge, assessed up to 30 days
SecondaryNet fluid lossper 24 hours at end of randomized therapyFluid input subtracted from total urine output
SecondaryWeight lossper 24 hours at end of randomized therapy
SecondaryCV mortality and cumulative HF rehospitalizations90 days after hospital dischargeBoth types of events will be combined in a total "event rate" compared between groups
SecondaryLength of staythrough hospital discharge, an average of 5 daysTime from initiation of randomized therapy to hospital discharge
Secondary
Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.
initiation of randomized therapy up to 12 hours after stopping randomized therapy
SecondarySevere electrolyte abnormalityinitiation of randomized therapy up to 72 hours after stopping randomized therapy
serum potassium \<3.0 mEq/L with ≥ 0.5 mEq/L decrease from initiation of randomized therapy, magnesium \<1.3 mEq/L with ≥0.5 mEq/L decrease from initiation of randomized therapy, or sodium \<125 mEq/L with ≥ 5.0 mEq/L decrease from initiation of randomized therapy
SecondaryWorsening heart failure requiring a higher level of HF therapyinitiation of randomized therapy up to 72 hours after stopping randomized therapy
SecondaryTinnitus or hearing loss lasting more than 30 minutesinitiation of randomized therapy up to 12 hours after stopping randomized therapy

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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