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

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06024889
• Other study ID #: H-23029822
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: February 9, 2024

Study information

• Verified date: February 2024
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 9, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Furosemide Injection
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.

Locations

Country	Name	City	State
Denmark	Amager-Hvidovre Hospital	Copenhagen	Capital Region Of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Grand

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the time 0 to 30 minutes