search
Back to results

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

Primary Purpose

Heart Failure，Congestive

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Furosemide
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure，Congestive focused on measuring Congestive Heart Failure, HFrEF, Biomarkers, Inflammation, Atrial Stretching, Furosemide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AOUP Paolo Giaccone
  • Internal Medicine Ward of Palermo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high dose furosemide plus HSS

high dose furosemide alone

Arm Description

Patients treated high dose furosemide plus HSS

Patients treated high dose furosemide alone

Outcomes

Primary Outcome Measures

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
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
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)

Secondary Outcome Measures

Full Information

First Posted
November 2, 2020
Last Updated
November 11, 2020
Sponsor
University of Palermo
search

1. Study Identification

Unique Protocol Identification Number
NCT04628325
Brief Title
Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure，Congestive
Keywords
Congestive Heart Failure, HFrEF, Biomarkers, Inflammation, Atrial Stretching, Furosemide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high dose furosemide plus HSS
Arm Type
Experimental
Arm Description
Patients treated high dose furosemide plus HSS
Arm Title
high dose furosemide alone
Arm Type
Active Comparator
Arm Description
Patients treated high dose furosemide alone
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Furosemide plus HSS
Intervention Description
Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)
Primary Outcome Measure Information:
Title
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching
Description
Assessment of differences between participants on atrial diameters evaluated with echocardiography
Time Frame
6 days
Title
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Fibrosis
Description
Assessment of differences between participants on atrial fibrosis evaluated with echocardiography
Time Frame
6 days
Title
Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Inflammatory Markers
Description
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)
Time Frame
6 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonino Tuttolomondo, PhD
Organizational Affiliation
Internal Medicine and Stroke Care Ward, University of Palermo, Italy
Official's Role
Study Director
Facility Information:
Facility Name
AOUP Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Internal Medicine Ward of Palermo University Hospital
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs