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

Sponsor

Johannes Grand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06024889

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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 15 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure	Drug: Furosemide Injection	Phase 1/Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Furosemide 80 mg of furosemide is administered IV	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.

Arm

Intervention/Treatment

Experimental: Furosemide

80 mg of furosemide is administered IV

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.

Outcome Measures

Primary Outcome Measures

Pulmonary fluid content [From the time 0 to 30 min.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amager-Hvidovre Hospital	Copenhagen	Capital Region Of Denmark	Denmark	2650

Sponsors and Collaborators

Johannes Grand

Investigators

Principal Investigator: Johannes Grand, Department of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johannes Grand, Principal Investigator, Copenhagen University Hospital, Hvidovre

ClinicalTrials.gov Identifier:

NCT06024889

Other Study ID Numbers:

H-23029822

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Failure

Furosemide

Study Results

No Results Posted as of Sep 6, 2023