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

NCT ID: NCT04628325

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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.

Conditions

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Heart Failureļ¼ŒCongestive

Keywords

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Congestive Heart Failure HFrEF Biomarkers Inflammation Atrial Stretching Furosemide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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high dose furosemide plus HSS

Patients treated high dose furosemide plus HSS

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

high dose furosemide alone

Patients treated high dose furosemide alone

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Interventions

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Furosemide

Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)

Intervention Type DRUG

Other Intervention Names

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Furosemide plus HSS

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Antonino Tuttolomondo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonino Tuttolomondo, PhD

Role: STUDY_DIRECTOR

Internal Medicine and Stroke Care Ward, University of Palermo, Italy

Locations

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AOUP Paolo Giaccone

Palermo, , Italy

Site Status

Internal Medicine Ward of Palermo University Hospital

Palermo, , Italy

Site Status

Countries

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Italy

Other Identifiers

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UPalermo

Identifier Type: -

Identifier Source: org_study_id