Clinical trial NCT06024889: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Heart Failure
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pulmonary fluid content
timeFrame: From the time 0 to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager-Hvidovre Hospital
state: Capital Region Of Denmark
Study officials:
affiliation: Department of Cardiology
name: Johannes Grand
role: PRINCIPAL_INVESTIGATOR
References: