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Trial record 66 of 133 for:    PAP children

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

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ClinicalTrials.gov Identifier: NCT03020043
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Birgit Assmus, PD Dr., Johann Wolfgang Goethe University Hospital

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 Frankfurt registry.

Condition or disease
Chronic Heart Failure

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: CardioMEMS Registry of the Frankfurt Heart Failure Center
Study Start Date : August 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose [ Time Frame: 5 years ]
    morbidity



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with New York Heart Association (NYHA) Class III with chronic heart failure, who had a hospitalisation for cardiac decompensation < 12 months
Criteria

Inclusion Criteria:

  • Implantation of CardioMEMS successful
  • Telemonitoring done by the Frankfurt heart Failure Center

Exclusion Criteria:

  • Unwillingness to participate in the registry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020043


Contacts
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Contact: Birgit Assmus, MD +49 69 6301 ext 84690 birgit.assmus@kgu.de
Contact: Andreas M Zeiher, MD +49 69 6301 ext 5789 zeiher@em.uni-frankfurt.de

Locations
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Germany
Klinikum Goethe University Recruiting
Frankfurt am Main, Germany, 60590
Contact: Birgit Assmus, MD    +49 69 6301 ext 84690    birgit.assmus@kgu.de   
Contact: Ester Herrmann, MD    +49 69 6301 ext 84690    ester.herrmann@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Birgit Assmus, MD Klinikum Goethe University Frankfurt

Additional Information:

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Responsible Party: Birgit Assmus, PD Dr., Prof. Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03020043     History of Changes
Other Study ID Numbers: FFM CardioMEMS Registry
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases