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

CardioMEMS Registry of the Frankfurt Heart Failure Center

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Birgit Assmus, MD; Phone Number: 84690 +49 69 6301; Email: birgit.assmus@kgu.de
• Study Contact Backup: Name: Andreas M Zeiher, MD; Phone Number: 5789 +49 69 6301; Email: zeiher@em.uni-frankfurt.de

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Klinikum Goethe University
    • Contact: Birgit Assmus, MD; Phone Number: 84690 +49 69 6301; Email: birgit.assmus@kgu.de
    • Contact: Ester Herrmann, MD; Phone Number: 84690 +49 69 6301; Email: ester.herrmann@kgu.de
  • Gießen, Germany, 35392
    • Not yet recruiting
    • University Hospital Justus-Liebe University
    • Contact: Birgit Assmus, MD; Phone Number: 42637 +49 641 985; Email: birgit.assmus@innere.med.uni-giessen.de
    • Contact: Ardeschir Ghofrani, MD; Phone Number: 42421 +49 641 985; Email: Ardeschir.Ghofrani@innere.med.uni-giessen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with New York Heart Association (NYHA) Class III with chronic heart failure (left and right ventricular heart failure, HFrEF, HFmrEF and HFpEF; +/- PH) , who had a hospitalisation for cardiac decompensation < 12 months

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose	morbidity	5 years

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: Birgit Assmus, MD, Klinikum Goethe University Frankfurt

Publications and helpful links

General Publications

• Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.
• Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Assmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.
• Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: FFM CardioMEMS Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO