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.
1 other identifier
interventional
136
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedNovember 13, 2020
November 1, 2020
2.3 years
November 2, 2020
November 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
high dose furosemide plus HSS
EXPERIMENTALPatients treated high dose furosemide plus HSS
high dose furosemide alone
ACTIVE COMPARATORPatients treated high dose furosemide alone
Interventions
Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)
Eligibility Criteria
You may qualify if:
- Congestive Heart Failure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AOUP Paolo Giaccone
Palermo, 90127, Italy
Internal Medicine Ward of Palermo University Hospital
Palermo, 90127, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Antonino Tuttolomondo, PhD
Internal Medicine and Stroke Care Ward, University of Palermo, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 13, 2020
Study Start
March 1, 2017
Primary Completion
June 30, 2019
Study Completion
May 1, 2020
Last Updated
November 13, 2020
Record last verified: 2020-11