Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05276219 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure

Study acronym: DECONGEST-AHF
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later May 31, 2027 → Jun 30, 2027
See other at-risk trials from Copenhagen University Hospital, Rigshospitalet

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 31, 2027 to Jun 30, 2027v8 Show 5 more changesShow less
    • Enrollment target: 1104 to 1041
    • Study sites: 4 to 5
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study title expanded, about 2 words
  2. Lead sponsor: Johannes Grand to Rigshospitalet, Denmarkv7 Show 4 more changesShow less
    • Primary and study completion dates: Dec 31, 2026 to May 31, 2027
    • Secondary endpoints: 9 to 6
    • Site contacts updated at 4 of 4 sites
    • Collaborators: 3 to 4
  3. Study sites: 3 to 4v6
  4. Site details revised at 1 of 3 sitesv5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: May 31, 2026 to Dec 31, 2026
    • Start date changed from estimate of Jun 1, 2023 to Sep 14, 2023
    • Study completion date: Aug 31, 2026 to Dec 31, 2026
    • Site details revised at 3 of 3 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: May 31, 2025 to May 31, 2026
    • Start date: Jun 1, 2022 to Jun 1, 2023
    • Study completion date: Aug 31, 2025 to Aug 31, 2026
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Background: Intravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission. Primary objective: To determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment. Design: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation. Intervention: Intervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups: * Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times. * Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible. * Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.
Trial Details
NCT Number NCT05276219
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Zealand University Hospital, Copenhagen University Hospital, Hvidovre, Bispebjerg Hospital, Herlev Hospital
Conditions
(from sponsor)		 Pulmonary Edema, Congestive Heart Failure, Acute Heart Failure
Related terms Heart Failure, Pulmonary Edema
Enrollment 1,041 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov