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
About this trial
This is an interventional diagnostic trial for Heart Murmurs
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
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
NCT ID
NCT04306991
First Posted
January 17, 2020
Last Updated
March 12, 2020
Sponsor
University Hospital, Angers
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
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Modifications of Heart Murmurs and Cardiac Output During Fever
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