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.
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 |
Verified date | November 2020 |
Source | University of Palermo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOUP Paolo Giaccone | Palermo | |
Italy | Internal Medicine Ward of Palermo University Hospital | Palermo |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
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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