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

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ClinicalTrials.gov Identifier: NCT04628325
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Antonino Tuttolomondo, University of Palermo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure，Congestive Drug: Furosemide Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Furosemide

Arms and Interventions
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Arm Intervention/treatment
Experimental: high dose furosemide plus HSS
Patients treated high dose furosemide plus HSS
 Drug: Furosemide
Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)
Other Name: Furosemide plus HSS
Active Comparator: high dose furosemide alone
Patients treated high dose furosemide alone
 Drug: Furosemide
Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)
Other Name: Furosemide plus HSS


Outcome Measures
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Primary Outcome Measures :
  1. Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Stretching [ Time Frame: 6 days ]
    Assessment of differences between participants on atrial diameters evaluated with echocardiography

  2. Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Atrial Fibrosis [ Time Frame: 6 days ]
    Assessment of differences between participants on atrial fibrosis evaluated with echocardiography

  3. Effects of Treatment With Moderate/High Doses of Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS) on Inflammatory Markers [ Time Frame: 6 days ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628325


Locations
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Italy
AOUP Paolo Giaccone
Palermo, Italy, 90127
Internal Medicine Ward of Palermo University Hospital
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
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Study Director: Antonino Tuttolomondo, PhD Internal Medicine and Stroke Care Ward, University of Palermo, Italy
More Information
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Responsible Party: Antonino Tuttolomondo, Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT04628325    
Other Study ID Numbers: UPalermo
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonino Tuttolomondo, University of Palermo:
Congestive Heart Failure
HFrEF
Biomarkers
 Inflammation
Atrial Stretching
Furosemide
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action