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

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Furosemide Injection
Sponsored by
Johannes Grand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Amager-Hvidovre HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Furosemide

Arm Description

80 mg of furosemide is administered IV

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
September 15, 2023
Sponsor
Johannes Grand
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1. Study Identification

Unique Protocol Identification Number
NCT06024889
Brief Title
Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.
Official Title
Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johannes Grand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Experimental
Arm Description
80 mg of furosemide is administered IV
Intervention Type
Drug
Intervention Name(s)
Furosemide Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary fluid content
Description
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
Time Frame
From the time 0 to 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Grand
Phone
+4538623862
Email
johannes.grand@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Chaidi
Phone
+4538623862
Email
nora.el.caidi@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Grand
Organizational Affiliation
Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amager-Hvidovre Hospital
City
Copenhagen
State/Province
Capital Region Of Denmark
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Grand, MD, PhD, MPH
Email
johannes.grand@regionh.dk
First Name & Middle Initial & Last Name & Degree
Nora Caidi
Email
nora.el.caidi@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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