Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

Study acronym: ESCALATE
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Aug 31, 2026 to Feb 28, 2027
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Oct 30, 2025 to Nov 22, 2025v17
  3. Primary completion date changed from estimate of Sep 30, 2026 to Oct 30, 2025
    • Study completion date: Dec 31, 2026 to Aug 31, 2026
    v16
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v15
  5. Re-verified, no change to tracked fieldsv14
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  1. Secondary endpoints revised (11)v13
  2. Re-verified, no change to tracked fieldsv12
  3. Primary endpoints: 2 to 1v11 Show 4 more changesShow less
    • Enrollment target: 484 to 474
    • Secondary endpoints: 2 to 11
    • Study description shortened, about 36 words
    • Study title shortened, about 3 words
  4. Eligibility criteria expanded, about 54 words
    • Site details revised at 1 of 2 sites
    v10
  5. Re-verified, no change to tracked fieldsv9
  6. Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 450 to 484
    • Site details revised at 2 of 2 sites
    v8
  7. Start date: Mar 1, 2022 to May 1, 2022v7
  8. Primary endpoints: 1 to 2
    • Enrollment target: 484 to 450
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 3 to 2
    v6
  9. Phase: Not applicable to Phase 2
    • Interventions: Protocolized diuretic therapy (Other) to Protocolized diuretic therapy (Drug)
    v5
  10. Lead sponsor: Sean Collins to Vanderbilt University Medical Centerv4 Show 4 more changesShow less
    • Primary completion date: May 31, 2025 to Sep 30, 2026
    • Start date: Jun 1, 2021 to Mar 1, 2022
    • Study completion date: Nov 30, 2025 to Dec 31, 2026
    • Study description expanded, about 1 word
  11. Collaborators shortened, about 7 wordsv3
  12. Study description expanded, about 2 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.
Trial Details
NCT Number NCT04481919
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)		 Heart Failure, Acute Heart Failure
Related terms Emergencies, Heart Failure
Enrollment 474 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov