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

University of Palermo

Status and phase: Completed; Phase 3

Conditions: Heart Failure，Congestive

Treatments: Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT04628325

UPalermo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

high dose furosemide plus HSS

Experimental group

Description:

Patients treated high dose furosemide plus HSS

Treatment:

Drug: Furosemide

high dose furosemide alone

Active Comparator group

Description:

Patients treated high dose furosemide alone

Treatment:

Drug: Furosemide