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

Heart Failure,Congestive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628325
• Other study ID #: UPalermo
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: November 2020
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 1, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Drug:
• Furosemide
Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Locations

Country	Name	City	State
Italy	AOUP Paolo Giaccone	Palermo
Italy	Internal Medicine Ward of Palermo University Hospital	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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