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

NCT ID: NCT06024889

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-02-09

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Furosemide

80 mg of furosemide is administered IV

Group Type: EXPERIMENTAL

Furosemide Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Grand

OTHER

Sponsor Role: lead

Responsible Party

Johannes Grand

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johannes Grand

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology

Locations

Amager-Hvidovre Hospital

Copenhagen, Capital Region of Denmark, Denmark

Countries

Denmark

References

El 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.

Reference Type: DERIVED

PMID: 38903022 (View on PubMed)

Other Identifiers

H-23029822

Identifier Type: -

Identifier Source: org_study_id