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

NCT06024889 | Completed Phase 1

• 1 other identifier: H-23029822
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Furosemide

EXPERIMENTAL

80 mg of furosemide is administered IV

Drug: Furosemide Injection

Interventions

Furosemide Injection 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.

Furosemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Grand: lead

Study Sites (1)

Amager-Hvidovre Hospital

Copenhagen, Capital Region of Denmark, 2650, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38903022 DERIVED

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Johannes Grand

  Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)