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

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT04628325

Collaborator

(none)

136

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure，Congestive	Drug: Furosemide	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: high dose furosemide plus HSS Patients treated high dose furosemide plus HSS	Drug: Furosemide Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) Other Names: Furosemide plus HSS
Active Comparator: high dose furosemide alone Patients treated high dose furosemide alone	Drug: Furosemide Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) Other Names: Furosemide plus HSS

Arm

Intervention/Treatment

Experimental: high dose furosemide plus HSS

Patients treated high dose furosemide plus HSS

Drug: Furosemide

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Other Names:

Furosemide plus HSS

Active Comparator: high dose furosemide alone

Patients treated high dose furosemide alone

Drug: Furosemide

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Other Names:

Furosemide plus HSS

Outcome Measures

Primary Outcome Measures

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)