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Heart Failure Decompensation And In-Hospital Mortality

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Unknown status
CT.gov ID
NCT04127162
Collaborator
(none)
50
Enrollment
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Background and objectives Heart failure is a leading cause of morbidity and mortality worldwide and it is a major cause of emergency department access for cardiovascular disease patients. Aim of this study is to identify the markers, based on short-term temporal repolarization dispersion, capable to individuate decompensated chronic heart failure (CHF) patients at high mortality risk.

Method: We will obtain the following variables from ECG monitor, via mobile phone, during 5-minute recordings in decompensated CHF patients: RR, QT end (QTe), QT peak (QTp) and T peak to T end (Te) and we calculated mean, standard deviation (SD) and normalized index (N).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Short-Period Temporal Dispersion Repolarization Markers and In-Hospital Mortality in Decompensated Heart Failure: A Pilot Study
    Anticipated Study Start Date :
    Dec 1, 2019
    Anticipated Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    alive
    dead

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [3 months]

      in-hospital mortality in decompensated heart failure patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • at least one symptom or sign compatible with a decompensation and/or a previous documented history of CHF
    Exclusion Criteria:

    • pneumonia

    • pulmonary embolism

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianfranco Piccirillo, professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT04127162
    Other Study ID Numbers:
    • CHF_NTproBNP
    First Posted:
    Oct 15, 2019
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gianfranco Piccirillo, professor, University of Roma La Sapienza
    Temporal Dispersion of Repolarization Phase
    proBNP
    QTVI
    QT
    Tpeak-Tend
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 15, 2019