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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04628325
Other study ID # UPalermo
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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