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Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03020043
Collaborator
(none)
500
Enrollment
2
Locations
112
Duration (Months)
250
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database.

    The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CardioMEMS Registry of the Frankfurt Heart Failure Center
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose [5 years]

      morbidity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Implantation of CardioMEMS successful

    • Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)

    Exclusion Criteria:
    • Unwillingness to participate in the registry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinikum Goethe University Frankfurt am Main Germany 60590
    2 University Hospital Justus-Liebe University Gießen Germany 35392

    Sponsors and Collaborators

    • Johann Wolfgang Goethe University Hospital

    Investigators

    • Principal Investigator: Birgit Assmus, MD, Klinikum Goethe University Frankfurt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Birgit Assmus, PD Dr., Prof. Dr. med., Johann Wolfgang Goethe University Hospital
    ClinicalTrials.gov Identifier:
    NCT03020043
    Other Study ID Numbers:
    • FFM CardioMEMS Registry
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Sep 18, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Sep 18, 2019