Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Heart Failure，Congestive

Intervention / Treatment
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* Drug: Furosemide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose furosemide plus HSS<br>Patients treated high dose furosemide plus HSS | Drug: Furosemide<br>* Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)<br>* Other names: Furosemide plus HSS;|
| Active Comparator: high dose furosemide alone<br>Patients treated high dose furosemide alone | Drug: Furosemide<br>* Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)<br>* Other names: Furosemide plus HSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching | Assessment of differences between participants on atrial diameters evaluated with echocardiography | 6 days | 
| Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Fibrosis | Assessment of differences between participants on atrial fibrosis evaluated with echocardiography | 6 days | 
| Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Inflammatory Markers | Evaluation of serum level of cytokines linked to inflammation and cardiac damage (IL-6, High-sensitive cardiac troponin T, Soluble interleukin 1 receptor-like 1, Galectin-3, N Terminal proB-type natriuretic peptide, C Reactive Protein) | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, HFrEF, Biomarkers, Inflammation, Atrial Stretching, Furosemide