Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure

NCT07577596 | Not Yet Recruiting Phase 4

• 2 other identifiers: INFUSEAHF2025-523589-26-00
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Heart Failure; Volume Overload

Outcome Measures

Primary Outcomes (1)

• Net weight loss 3 days after randomization

  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

Secondary Outcomes (4)

• Net weight loss 2 days after randomization

  From randomization to approximately 48 hours

• Change in dyspnea 3 days after randomization

  From randomization to approximately 72 hours

• Days alive out of hospital to Day 30

  From randomization to 30 days

• Length of hospital stay

  From randomization up to 30 days

Other Outcomes (8)

• Net weight loss 1 day after randomization

  From randomization to approximately 24 hours

• Change in dyspnea 1 day after randomization

  From randomization to approximately 24 hours

• Change in dyspnea 2 days after randomization

  From randomization to approximately 48 hours

Study Arms (2)

Continuous infusion preceded by a loading dose

EXPERIMENTAL

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.

Drug: Intravenous furosemide continuous infusion

Bolus injections three times a day

EXPERIMENTAL

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.

Drug: Intravenous furosemide bolus injections

Interventions

Intravenous furosemide continuous infusion DRUG

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.

Also known as: Furosemide infusion

Continuous infusion preceded by a loading dose

Intravenous furosemide bolus injections DRUG

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.

Also known as: Furosemide bolus injections

Bolus injections three times a day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Related Links

• EU Clinical Trials register entry for INFUSE-AHF

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esben Merrild, MD

  Department of Medicine, Randers Regional Hospital

  STUDY DIRECTOR

• Bo Løfgren, MD PhD

  Department of Medicine, Randers Regional Hospital

  STUDY CHAIR

• Henrik Birn, MD PhD DMSc

  Department of Renal Medicine, Aarhus University Hospital

  STUDY CHAIR

• Kasper G Lauridsen, MD PhD

  Department of Medicine, Randers Regional Hospital

  STUDY CHAIR

• Christian B Poulsen, MD PhD

  Private Organization

  STUDY CHAIR

Central Study Contacts

Esben Merrild, MD

CONTACT

+4522996026; esbenmerrild@clin.au.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Participants, care providers, investigators, and outcome assessors are not masked to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to one of two parallel treatment arms: Intravenous furosemide administered as continuous infusion preceded by a loading dose, or intravenous furosemide administered as bolus injections three times a day.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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.
• Access Criteria: 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.