Fact CheckerSign in

NCT06024889CompletedPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 16 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
20 (actual)
First submitted
23 Aug 2023
Start date
1 Sept 2023
Primary completion date
9 Feb 2024
Lead sponsor
Johannes Grand
NCT number
NCT06024889

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 20
  • From 1 Sept 2023 to the primary completion date, 9 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \> 180 or \< 40 bpm.
  • Known chronic obstructive lung disease
  • 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

Other

  • More than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration
  • Pacemaker or ICD on the right side
  • Height less than 155 cm or higher than 200 cm
  • BMI of less than 18 or more than 38

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amager-Hvidovre Hospital
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.