Acute Heart FailurePhase 1/2NCT06024889
Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.
A Phase 1/2 study testing Furosemide Injection in people with Acute Heart Failure, run by Johannes Grand at 1 site in Denmark.
Trial summary
Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Furosemide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 9 Feb 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Clinical diagnosis of acute heart failure requiring hospitalization
- Systolic blood pressure ≥100 mmHg
- Oxygen saturation <94% or need of oxygen
- Confirmed pulmonary congestion on x-ray or ReDS
Who cannot join
- More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration
- Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm.
- Known chronic obstructive lung disease
- Pacemaker or ICD on the right side
- Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
- Wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin
- Height less than 155 cm or higher than 200 cm
- BMI of less than 18 or more than 38
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Amager-Hvidovre Hospital
Copenhagen, Capital Region of Denmark, 2650
About this study
Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure. However, no randomized clinical trials have investigated loop diuretics versus other interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of furosemide is based in studies from the 1970s. In this study, we aim to assess the acute effect of furosemide on cardiac filling pressures and pulmonary congestion.
Hypothesis:
Read more
Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac filling pressures and pulmonary congestion before significant diuresis occurs.
Design:
A prospective, interventional study including 20 patients admitted due to a clinical diagnosis of acute heart failure with pulmonary congestion.
Intervention:
80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
Read the detailed description
Prospective observational study of the acute and subacute effects of furosemide in patients with acute heart failure.
After inclusion, 80 mg of furosemide is administered IV.
Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
- Conditions
- Acute Heart Failure
- Being tested
- Furosemide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide InjectionDrug
Intravenous administration of 80 mg furosemide is followed by assessing blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, and ultrasound examination of heart and lungs, including assessment of filling pressures with doppler and strain analysis. These measurements are repeated at multiple time points until 6 hours have elapsed.
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Experimental | 80 mg of furosemide is administered IV Receives: Drug: Furosemide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary fluid content
Remote dielectric sensing (ReDS) is a non-invasive electromagnetic-based tool that measures absolute lung fluid content and gives the fluid content in a proportional value ranging from 0-100 percent. 20-35% represent normal values.
The primary outcome will be change in pulmonary fluid content after administration of furosemide
Measured: From the time 0 to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Grand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johannes Grand, Copenhagen University Hospital, Hvidovre
- Investigators
- Johannes Grand, Principal investigator, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024889
- Sponsor's protocol ID
- H-23029822
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Caidi NO, Lukoschewitz JD, Taraldsen IA, Hove J, Seven E, Dixen U, Grund F, Petersen M, Foss NB, Grand J. Acute haemodynamic and diuretic effects of intravenous furosemide in acute heart failure. Dan Med J. 2026 Feb 19;73(3):A07250556. doi: 10.61409/A07250556.
PubMed 41773006El Caidi NO, Lukoschewitz JD, Nielsen OW, Hove J, Seven E, Dixen U, Grund F, Petersen M, Foss NB, Grand J. The acute effects of furosemide in acute heart failure assessed by remote dielectric sensing. A protocol. Dan Med J. 2024 Jun 12;71(7):A11230697. doi: 10.61409/A11230697.
PubMed 38903022
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.
- ClinicalTrials.gov ID
- NCT06024889
- Acronym / sponsor ID
- H-23029822
- Conditions
- Acute Heart Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johannes GrandUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 6 Sep 2023 (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.
Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure. However, no randomized clinical trials have investigated loop diuretics versus other interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of furosemide is based in studies from the 1970s. In this study, we aim to assess the acute effect of furosemide on cardiac filling pressures and pulmonary congestion.
Hypothesis:
Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac filling pressures and pulmonary congestion before significant diuresis occurs.
Design:
A prospective, interventional study including 20 patients admitted due to a clinical diagnosis of acute heart failure with pulmonary congestion.
Intervention:
80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
Detailed description
Prospective observational study of the acute and subacute effects of furosemide in patients with acute heart failure.
After inclusion, 80 mg of furosemide is administered IV.
Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. Measurements are repeated at several time points until 6 hours have passed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Experimental | Drug: Furosemide Injection80 mg of furosemide is administered IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Clinical diagnosis of acute heart failure requiring hospitalization
- Systolic blood pressure ≥100 mmHg
- Oxygen saturation <94% or need of oxygen
- Confirmed pulmonary congestion on x-ray or ReDS
Key exclusion criteria (8 listed)
- More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration
- Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR > 180 or < 40 bpm.
- Known chronic obstructive lung disease
- Pacemaker or ICD on the right side
- Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma)
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 |
|---|---|---|
| Furosemide InjectionIntravenous administration of 80 mg furosemide is followed by assessing blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, and ultrasound examination of heart and lungs, including assessment of filling pressures with doppler and strain analysis. These measurements are repeated at multiple time points until 6 hours have elapsed. | Drug | Furosemide |
Primary outcome
Pulmonary fluid content
Time frame: From the time 0 to 30 minutes
Remote dielectric sensing (ReDS) is a non-invasive electromagnetic-based tool that measures absolute lung fluid content and gives the fluid content in a proportional value ranging from 0-100 percent. 20-35% represent normal values. The primary outcome will be change in pulmonary fluid content after administration of furosemide
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 41773006El Caidi NO, Lukoschewitz JD, Taraldsen IA, Hove J, Seven E, Dixen U, Grund F, Petersen M, Foss NB, Grand J. Acute haemodynamic and diuretic effects of intravenous furosemide in acute heart failure. Dan Med J. 2026 Feb 19;73(3):A07250556. doi: 10.61409/A07250556.
- Derived from this study: PubMed 38903022El Caidi NO, Lukoschewitz JD, Nielsen OW, Hove J, Seven E, Dixen U, Grund F, Petersen M, Foss NB, Grand J. The acute effects of furosemide in acute heart failure assessed by remote dielectric sensing. A protocol. Dan Med J. 2024 Jun 12;71(7):A11230697. doi: 10.61409/A11230697.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Johannes Grand principal investigator
Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Furosemide Injection in people with Acute Heart Failure, run by Johannes Grand 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 16 Feb 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary fluid content (time frame: From the time 0 to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024889, which also lists 2 linked publications.
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 16 Feb 2024.