Clinical trial NCT04628325: Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
Official title: Effects of Treatment With Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching, Fibrosis and Inflammatory Markers in Subjects With Heart Failure With Reduced Ejection Fraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure，Congestive
Keywords: Congestive Heart Failure
HFrEF
Biomarkers
Inflammation
Atrial Stretching
Furosemide
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators sought to evaluate the effectiveness of treatment with furosemide + HSS in terms of reduction of serum levels of some chosen markers of heart failure and the response in terms of these markers at a compensated state after an acute saline load.

Detailed description: All consecutive patients aged \>18 years with a diagnosis of acute heart failure or exacerbation in chronic heart failure due to heart failure with reduced ejection fraction ( HFrEF) admitted to the ward of Internal Medicine were enrolled from March 2017 to June 2019. Enrolled subjects were treated with treatment with hypertonic saline solutions + furosemide e.v and control subjects with congestive heart failure randomized to treatment with intravenous furosemide only. Chronic kidney disease patients undergoing dialysis replacement, acute coronary syndrome, myocarditis, pneumonia, myopathies, neoplasms have been excluded.

Patients underwent at T0 (at 24 hours from admission), T1 (after 6-8 days after treatment with high dose furosemide+ HSS ), T2 (after a saline load) venepuncture to obtain venous blood samples for the determination of serum concentrations of N terminal pro B-type natriuretic peptide, High-sensitive cardiac troponin T, Galectin 3, IL-6.

Eligibility criteria: Inclusion Criteria:

* Congestive Heart Failure

Exclusion Criteria:

* Acute myocarditis
* active pulmonary or liver diseases
* autoimmune disorders
* infections
* malignant diseases
* muscle disorders
* renal insufficiency
* chronic inflammatory diseases
* rheumatological diseases
* haematological diseases
* chronic treatment with anti-inflammatory drugs

Primary outcomes:
measure: Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching
timeFrame: 6 days
measure: Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Fibrosis
timeFrame: 6 days
measure: Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Inflammatory Markers
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: AOUP Paolo Giaccone
city: Palermo
country: Italy
facility: Internal Medicine Ward of Palermo University Hospital
Study officials:
affiliation: Internal Medicine and Stroke Care Ward, University of Palermo, Italy
name: Antonino Tuttolomondo, PhD
role: STUDY_DIRECTOR
References: