Modifications of Heart Murmurs and Cardiac Output During Fever

NCT04306991 | Unknown FDA Device

• 1 other identifier: 49RC19_0202
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Murmurs; Fever

Outcome Measures

Primary Outcomes (1)

• Murmur intensity

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

  up to 7 days

Secondary Outcomes (1)

• Cardiac output (echocardiography)

  up to 7 days

Study Arms (2)

Fever

EXPERIMENTAL

Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography

Device: Auscultation using an electronic stethoscope (EKO CORE 4)

Apyrexia

EXPERIMENTAL

Auscultation using an electronic stethoscope Measurement of cardiac output using echocardiography

Device: Auscultation using an electronic stethoscope (EKO CORE 4)

Interventions

Auscultation using an electronic stethoscope (EKO CORE 4) DEVICE

* Auscultation using an electronic stethoscope (EKO CORE 4). Record of at least 3 cardiac cycles. * Measurement of cardiac output using echocardiography.

Apyrexia; Fever

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Heart Murmurs; Fever

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Study Officials

• Vincent Dubee, MD, PhD

  University Hospital, Angers

  STUDY DIRECTOR

Central Study Contacts

Vincent Dubee, MD, PhD

CONTACT

0033665807022; vincent.dubee@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Each patient will be auscultated twice: * during a febrile episode (body temperature \>38.5°C) * after resolution of fever (body temperature \< 37.5°C)

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: March 13, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share