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Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.

Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06024889
Enrollment
20
Registered
2023-09-06
Start date
2023-09-01
Completion date
2024-02-09
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Heart Failure

Brief 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. 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.

Interventions

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.

Sponsors

Johannes Grand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. Clinical diagnosis of acute heart failure requiring hospitalization 3. Systolic blood pressure ≥100 mmHg 4. Oxygen saturation \<94% or need of oxygen 5. Confirmed pulmonary congestion on x-ray or ReDS

Exclusion criteria

1. More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration 2. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm. 3. Known chronic obstructive lung disease 4. Pacemaker or ICD on the right side 5. Congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma) 6. Wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin 7. Height less than 155 cm or higher than 200 cm 8. BMI of less than 18 or more than 38

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary fluid contentFrom the time 0 to 30 minutesRemote 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026