Acute Heart FailurePhase 4INFUSE-AHFNCT07577596
Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure
A Phase 4 study testing Intravenous furosemide continuous infusion and Intravenous furosemide bolus injections in people with Acute Heart Failure and Volume Overload, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Volume Overload
- What is being tested?
- Intravenous furosemide continuous infusion and Intravenous furosemide bolus injections
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jun 2026to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Medicine, Randers Regional Hospital
Randers, 8930
Esben Merrild, MD, +4560596951, esbenmerrild@clin.au.dk
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Heart Failure, Volume Overload
- Being tested
- Intravenous furosemide continuous infusion, Intravenous furosemide bolus injections
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous furosemide continuous infusionDrug
Also called Furosemide 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.
Intravenous furosemide bolus injectionsDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous furosemide bolus injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to approximately 72 hours
Secondary outcomes (4)
Net weight loss 2 days after randomization
Net change in body weight from randomization to the morning of Day 3, corresponding to approximately 48 hours after randomization.
Measured: From randomization to approximately 48 hours
Change in dyspnea 3 days after randomization
Change in dyspnea assessed using a Visual Analogue Scale from randomization to the morning of Day 4, corresponding to approximately 72 hours after randomization.
Measured: From randomization to approximately 72 hours
Days alive out of hospital to Day 30
Number of days alive and out of hospital from randomization to Day 30.
Measured: From randomization to 30 days
Length of hospital stay
Duration of the index hospital admission.
Measured: From randomization up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start30 Jun 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Esben Merrild, MD, Study director, Department of Medicine, Randers Regional HospitalBo Løfgren, MD PhD, Study chair, Department of Medicine, Randers Regional HospitalHenrik Birn, MD PhD DMSc, Study chair, Department of Renal Medicine, Aarhus University HospitalKasper G Lauridsen, MD PhD, Study chair, Department of Medicine, Randers Regional HospitalChristian B Poulsen, MD PhD, Study chair, Private Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577596
- Sponsor's protocol ID
- INFUSEAHF
- Other IDs
- 2025-523589-26-00, 2025
- Acronym
- INFUSE-AHF
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)
- ClinicalTrials.gov ID
- NCT07577596
- Acronym / sponsor ID
- INFUSE-AHF / INFUSEAHF
- Conditions
- Acute Heart Failure, Volume Overload
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion preceded by a loading dose | Experimental | Drug: Intravenous furosemide continuous infusionParticipants 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. |
| Bolus injections three times a day | Experimental | Drug: Intravenous furosemide bolus injectionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous furosemide continuous infusionAlso: Furosemide infusionIntravenous 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. | Drug | Continuous infusion preceded by a loading dose |
| Intravenous furosemide bolus injectionsAlso: Furosemide bolus injectionsIntravenous 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 | Bolus injections three times a day |
Primary outcome
Net weight loss 3 days after randomization
Time frame: 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.
4 secondary outcomes
Net weight loss 2 days after randomization
Time frame: From randomization to approximately 48 hours
Change in dyspnea 3 days after randomization
Time frame: From randomization to approximately 72 hours
Days alive out of hospital to Day 30
Time frame: From randomization to 30 days
Length of hospital stay
Time frame: From randomization up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- EU Clinical Trials register entry for INFUSE-AHFLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esben Merrild, MD study director
Department of Medicine, Randers Regional Hospital
Bo Løfgren, MD PhD study chair
Department of Medicine, Randers Regional Hospital
Henrik Birn, MD PhD DMSc study chair
Department of Renal Medicine, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous furosemide continuous infusion and Intravenous furosemide bolus injections in people with Acute Heart Failure and Volume Overload, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esben Merrild, MD (+4522996026, esbenmerrild@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net weight loss 3 days after randomization (time frame: From randomization to approximately 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.