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Modifications of Heart Murmurs and Cardiac Output During Fever (FeMur)

Primary Purpose

Heart Murmurs, Fever

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auscultation using an electronic stethoscope (EKO CORE 4)
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Murmurs

Eligibility Criteria

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

Inclusion Criteria:

  • Hospitalized febrile patients (body temperature > 38.5°C)
  • Aged 18 or older
  • Agreement to participate to the study

Exclusion Criteria:

  • Patients treated with beta-blockers, verapamil, or diltiazem
  • Patients with atrial fibrillation
  • Pregnancy or breastfeeding
  • Patients with severe psychiatric disorder
  • Patients with diminished heart sounds

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Fever

    Apyrexia

    Arm Description

    Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography

    Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography

    Outcomes

    Primary Outcome Measures

    Murmur intensity
    Proportion of patients with a modification of heart sounds (computerized comparison of murmur intensity during fever and during apyrexia)

    Secondary Outcome Measures

    Cardiac output (echocardiography)
    Comparison of cardiac output measured using echocardiography during fever and after resolution of fever (apyrexia)

    Full Information

    First Posted
    January 17, 2020
    Last Updated
    March 12, 2020
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04306991
    Brief Title
    Modifications of Heart Murmurs and Cardiac Output During Fever
    Acronym
    FeMur
    Official Title
    Modifications of Heart Murmurs and Cardiac Output During Fever
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The combination of fever and auscultation of a heart murmur suggests the diagnosis of endocarditis. However, fever itself increases cardiac output and could therefore modify heart sounds. The aim of the FeMur study is to measure the modification of heart sounds during fever. Heart sounds of 15 hospitalized febrile patients with a heart murmur will be recorded using an electronic stethoscope before and after resolution of fever. The records will be analyzed using a computerized application in order to quantify the intensity of heart murmurs.
    Detailed Description
    Fever is an frequently observed during acute illnesses, particularly infectious diseases. The hemodynamic consequences of fever have been extensively studied. Fever leads to an acceleration of heart rate (approximately 8.5 bpm per degree celsius) and to a moderate drop in blood pressure. Cardiac output increases in the context of heat stress as a result of complex physiological adaptations, including heart rate and systolic function increase while preload and after load decrease. However, there are no studies on the specific consequences of fever on heart sounds. The question is important since auscultation of a heart murmur in a febrile patient suggests the diagnosis of endocarditis. In endocarditis, the heart murmur, which is present in 85% of cases, is due to the mutilation of heart valves, which requires urgent diagnostic and therapeutic management. Suspicion of endocarditis requires emergency cardiac ultrasonography. However, the proportion of patients with actual endocarditis among patients with heart murmur and fever is low. This could arise from the fact that fever itself may increase or trigger a heart murmur. Indeed, any increase in cardiac output may generate audible turbulence when blood is pumped across a heart valve. Functional or inorganic murmurs are murmurs triggered by changes in cardiac output or blood viscosity, as opposed to organic murmurs reflecting an anatomical abnormality in the heart. Certain characteristics of the murmur and the context of occurrence can guide the clinical toward one of these two situations, but distinguishing functional from organic murmurs is most often difficult. The impact of fever on cardiac murmurs has not been experimentally demonstrated. This is the aim of the FeMur study. For this purpose, heart sounds of 15 patients will be recorded during a febrile ilness and after resolution of fever using an electronic stethoscope and analyzed using a computer application. The average intensity of heart murmurs will be compared between the two periods in order to determine the impact of fever.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Murmurs, Fever

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Each patient will be auscultated twice: during a febrile episode (body temperature >38.5°C) after resolution of fever (body temperature < 37.5°C)
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fever
    Arm Type
    Experimental
    Arm Description
    Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography
    Arm Title
    Apyrexia
    Arm Type
    Experimental
    Arm Description
    Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography
    Intervention Type
    Device
    Intervention Name(s)
    Auscultation using an electronic stethoscope (EKO CORE 4)
    Intervention Description
    Auscultation using an electronic stethoscope (EKO CORE 4). Record of at least 3 cardiac cycles. Measurement of cardiac output using echocardiography.
    Primary Outcome Measure Information:
    Title
    Murmur intensity
    Description
    Proportion of patients with a modification of heart sounds (computerized comparison of murmur intensity during fever and during apyrexia)
    Time Frame
    up to 7 days
    Secondary Outcome Measure Information:
    Title
    Cardiac output (echocardiography)
    Description
    Comparison of cardiac output measured using echocardiography during fever and after resolution of fever (apyrexia)
    Time Frame
    up to 7 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized febrile patients (body temperature > 38.5°C) Aged 18 or older Agreement to participate to the study Exclusion Criteria: Patients treated with beta-blockers, verapamil, or diltiazem Patients with atrial fibrillation Pregnancy or breastfeeding Patients with severe psychiatric disorder Patients with diminished heart sounds
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincent Dubee, MD, PhD
    Phone
    0033665807022
    Email
    vincent.dubee@chu-angers.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent Dubee, MD, PhD
    Organizational Affiliation
    University Hospital, Angers
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Modifications of Heart Murmurs and Cardiac Output During Fever

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