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Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)

1 juli 2026 uppdaterad av: University of Aarhus

Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)

Acute heart failure is a condition where the heart suddenly cannot pump blood well enough for the body's needs. Many people admitted to the hospital with acute heart failure have too much fluid in the body. This can cause shortness of breath, swelling, and the need for treatment with water-removing medicine.

Furosemide is a commonly used water-removing medicine that is given into a vein to treat fluid overload. It can be given in different ways. One way is as a continuous infusion, where the medicine is given slowly over time through a pump. Another way is as repeated injections given several times a day. It is not known whether one of these ways is better than the other for removing excess fluid in people with acute heart failure.

The purpose of this study is to compare two ways of giving furosemide into a vein: Continuous infusion started with an initial extra dose, and bolus injections given three times a day. About 436 adults admitted to hospitals in Denmark with acute heart failure and fluid overload will take part. Participants will be randomly assigned to one of the two treatment groups. This means that chance will decide which treatment method each participant receives.

The main thing the researchers will measure is how much body weight participants lose about 3 days after randomization. Weight loss is used as a measure of how much excess fluid has been removed.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

INFUSE-AHF is an investigator-initiated, multicentre, open-label, pragmatic, randomized clinical trial conducted at hospitals in Denmark. The trial compares two commonly used ways of administering intravenous furosemide in adults hospitalized with acute heart failure and volume overload: Continuous infusion preceded by a loading dose, and bolus injections administered three times a day.

The rationale for the trial is that intravenous loop diuretics are standard treatment for acute heart failure with volume overload, but the optimal method of administration remains uncertain. Previous evidence has not established whether continuous infusion or bolus injections are superior. In addition, continuous infusion without an initial loading dose may delay achievement of effective plasma concentrations. The INFUSE-AHF trial, therefore, specifically evaluates continuous infusion preceded by a loading dose compared with bolus injections three times a day.

The trial includes three phases. The inclusion phase starts when a potential participant is identified during hospitalization and ends when the first dose of trial treatment is administered. The treatment phase starts with the first administration of intravenous furosemide and continues until the last weight measurement on the morning of Day 4. The follow-up phase starts after the treatment phase and continues until 30 days after the first injection.

Participants are randomized in a 1:1 ratio to one of the two treatment strategies. In the continuous infusion group, an initial loading dose is administered immediately before the infusion is started. In the bolus group, furosemide is administered as bolus injections three times a day, and the first bolus includes an additional dose to mirror the loading dose strategy. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at admission using a predefined dosing algorithm. During the first part of the treatment period, doses are protocolized. On the morning of Day 3, the treating clinician may increase the dose, maintain the same dose, or stop intravenous treatment according to the protocol and the participant's clinical status.

Approximately 436 participants will be enrolled. The primary endpoint is net weight loss 3 days, equivalent to approximately 72 hours, after randomization. Secondary endpoints include net weight loss 2 days after randomization, change in dyspnea on a Visual Analog Scale 3 days after randomization, days alive out of hospital to Day 30, and length of hospital stay. Safety endpoints include acute kidney injury, severe electrolyte disturbances, incidents, and side effects.

Studietyp

Interventionell

Inskrivning (Beräknad)

436

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Danmark
      • Randers, Danmark, 8930
        • Rekrytering
        • Department of Medicine, Randers Regional Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Clinical diagnosis of acute heart failure with volume overload
  • At least 1 sign of volume overload
  • Anticipated intravenous furosemide treatment for at least 3 days
  • Age 18 years or older

Exclusion Criteria:

  • Shock
  • Patient requiring treatment with inotropes or vasopressors
  • Current or planned use of renal replacement therapy or ultrafiltration
  • Patient with a renal transplant
  • Patients who are pregnant or breastfeeding
  • Severe hypokalaemia, defined as potassium less than 2.5 mmol/L, or severe hyponatremia, defined as sodium less than 125 mmol/L
  • Allergy to furosemide and its components

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Continuous infusion preceded by a loading dose
Participants receive intravenous furosemide administered as a continuous infusion preceded by an initial loading dose. The loading dose is administered immediately before initiation of the infusion. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Läkemedel: Intravenous furosemide continuous infusion
Intravenous furosemide administered as a continuous infusion preceded by a loading dose. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Andra namn:
  • Furosemide infusion
Experimentell: Bolus injections three times a day
Participants receive intravenous furosemide administered as bolus injections three times a day. The first bolus injection includes an additional dose to mirror the loading dose strategy used in the continuous infusion group. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Läkemedel: Intravenous furosemide bolus injections
Intravenous furosemide administered as bolus injections three times a day. The first bolus injection includes an additional dose to mirror the loading dose strategy used in the continuous infusion group. Daily intravenous furosemide doses are determined according to the participant's oral loop diuretic dose at hospital admission using a predefined dosing algorithm.
Andra namn:
  • Furosemide bolus injections

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Net weight loss 3 days after randomization
Tidsram: From randomization to approximately 72 hours
Net change in body weight from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
From randomization to approximately 72 hours

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Net weight loss 2 days after randomization
Tidsram: From randomization to approximately 48 hours
Net change in body weight from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
From randomization to approximately 48 hours
Change in dyspnea 3 days after randomization
Tidsram: From randomization to approximately 72 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
From randomization to approximately 72 hours
Days alive out of hospital to Day 30
Tidsram: From randomization to 30 days
Number of days alive and out of hospital from randomization to Day 30.
From randomization to 30 days
Length of hospital stay
Tidsram: From randomization up to 30 days
Duration of the index hospital admission.
From randomization up to 30 days

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Net weight loss 1 day after randomization
Tidsram: From randomization to approximately 24 hours
Net change in body weight from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
From randomization to approximately 24 hours
Change in dyspnea 1 day after randomization
Tidsram: From randomization to approximately 24 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 2, corresponding to approximately 24 hours after randomization.
From randomization to approximately 24 hours
Change in dyspnea 2 days after randomization
Tidsram: From randomization to approximately 48 hours
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
From randomization to approximately 48 hours
Death from any cause after 30 days
Tidsram: From randomization to 30 days
All-cause mortality assessed 30 days after randomization.
From randomization to 30 days
Rehospitalization from any cause after 30 days
Tidsram: From randomization to 30 days
Rehospitalization from any cause assessed 30 days after randomization.
From randomization to 30 days
Acute kidney injury
Tidsram: From randomization to approximately 72 hours
Proportion of participants with acute kidney injury grade 2 or higher as defined by KDIGO criteria during the treatment phase.
From randomization to approximately 72 hours
Severe electrolyte disturbances
Tidsram: From randomization to approximately 72 hours
Proportion of participants with severe hypokalaemia, severe hyponatremia, or severe hypernatremia, defined as potassium less than 2.5 mmol/L, sodium less than 125 mmol/L, or sodium greater than 155 mmol/L.
From randomization to approximately 72 hours
Incidents and side effects
Tidsram: From randomization to 30 days
Treatment-emergent serious adverse events, including incidents and side effects.
From randomization to 30 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Aarhus

Samarbetspartners

Central Denmark Region

Utredare

  • Studierektor: Esben Merrild, MD, Department of Medicine, Randers Regional Hospital
  • Studiestol: Bo Løfgren, MD PhD, Department of Medicine, Randers Regional Hospital
  • Studiestol: Henrik Birn, MD PhD DMSc, Department of Renal Medicine, Aarhus University Hospital
  • Studiestol: Kasper G Lauridsen, MD PhD, Department of Medicine, Randers Regional Hospital
  • Studiestol: Christian B Poulsen, MD PhD, Private Organization

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 juni 2026

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

5 maj 2026

Första postat (Faktisk)

11 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • INFUSEAHF
  • 2025-523589-26-00 (Ctis)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

De-identified individual participant data may be made available after publication of the main trial results, subject to approval by the Steering Committee and in accordance with applicable data protection legislation. All trial data will be pseudo-anonymized and stored for 25 years after the end of the trial in accordance with Danish law and GDPR requirements. Data sharing will be considered on a case-by-case basis for scientifically sound research proposals that do not conflict with ongoing or planned analyses, intellectual property considerations, or the governance and objectives of the trial. Requests for data access must be submitted to the Scientific Lead or Coordinating Investigator and will be evaluated by the Steering Committee based on methodological quality, feasibility, and compatibility with the scientific, ethical, and strategic framework of the trial. There is no obligation for unrestricted, automatic, or indefinite data sharing.

Tidsram för IPD-delning

After publication of the main trial results. Data will be considered available on a case-by-case basis, and there is no predefined end date for availability.

Kriterier för IPD Sharing Access

Requests must be submitted to the Scientific Lead or Coordinating Investigator and will be evaluated by the Steering Committee. Access may be granted for scientifically sound research proposals that do not conflict with ongoing or planned analyses, intellectual property considerations, or the governance and objectives of the trial. Requests will be evaluated based on methodological quality, feasibility, and compatibility with the scientific, ethical, and strategic framework of the trial.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

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