Clinical trial NCT03020043: Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)
Official title: CardioMEMS Registry of the Frankfurt Heart Failure Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum Goethe University
city: Gießen
country: Germany
facility: University Hospital Justus-Liebe University
Study officials:
affiliation: Klinikum Goethe University Frankfurt
name: Birgit Assmus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.