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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04628325

Enrollment

136

Registered

2020-11-13

Start date

2017-03-01

Completion date

2020-05-01

Last updated

2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure，Congestive

Keywords

Congestive Heart Failure, HFrEF, Biomarkers, Inflammation, Atrial Stretching, Furosemide

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.

Interventions

DRUGFurosemide

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026