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

Recruiting

• Conditions: Chronic Heart Failure

• Registration Number: NCT03020043
• Lead Sponsor: 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 multicenbtric registry.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose	5 years	morbidity

Trial Locations

Locations (2)

Klinikum Goethe University; 🇩🇪 Frankfurt am Main, Germany

University Hospital Justus-Liebe University; 🇩🇪 Gießen, Germany