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

Phase 3

Completed

• Conditions: Heart Failure，Congestive
• Interventions: Drug: Furosemide

• Registration Number: NCT04628325
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-06-30
• Study Completion: 2020-05-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose furosemide plus HSS	Furosemide	Patients treated high dose furosemide plus HSS
high dose furosemide alone	Furosemide	Patients treated high dose furosemide alone

Primary Outcome Measures

Name	Time	Method
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching	6 days	Assessment of differences between participants on atrial diameters evaluated with echocardiography
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Fibrosis	6 days	Assessment of differences between participants on atrial fibrosis evaluated with echocardiography
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Inflammatory Markers	6 days	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)

Trial Locations

Locations (2)

AOUP Paolo Giaccone; 🇮🇹 Palermo, Italy

Internal Medicine Ward of Palermo University Hospital; 🇮🇹 Palermo, Italy