Randomized, parallel group controlled study examines the effect of supporting the Heart failure supply through pulmonary arterial (PA) pressure measurement with the CardioMEMS™ HF system to hard endpoints, safety and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and at least once in the past 12 months for HF were admitted to hospital. All patients receive basic care, which is based on structured telephone contact (between the care center, patient and family doctor) to optimize guideline compliant therapy. In the intervention group a PA pressure sensor is (CardioMEMS™-HF Sensor) implanted. These patients are structured by specially trained non-medical personnel aftercare with additional inclusion of the PA pressure values: adjusted to the basis of the information collected in PA monitoring the therapy is optimized. The follow-up period until the primary endpoint is 12 months. In addition, data on longtime-mortality is being collected towards the end of the study for all study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
554
CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.
SLK-Kliniken GmbH - Klinikum am Plattenwald
Bad Friedrichshall, Germany
Kerckhoff-Klinik Forschungs GmbH
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
BG Unfallkrankenhaus Berlin
Berlin, Germany
Charité Universitätsmedizin (Campus Mitte, Campus Virchow, Campus Benjamin Franklin)
Berlin, Germany
Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death
Composite endpoint of number of unplanned HF-related rehospitalisations or all-cause death
Time frame: 12 months
Primary safety endpoint: device-related complications
Rate of Device / System related complications
Time frame: 12 months
Co-primary safety endpoint: sensor failure
Rate of sensor failures
Time frame: 12 months
Major secondary endpoint: changes in disease-related quality of life
Change in quality of life score after 6 and 12 month measured by Kansas City Cardiomyopathy questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: 6 and 12 months
Changes in generic health-related quality of life
Change in Quality of Life score after 6 and 12 month measures by EQ-5D questionnaire. The EQ-5D-5L descriptive system comprises the five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (1 - 5, where higher scores indicate more severe problems). The EQ VAS records the respondent's overall current health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine - 100' and 'The worst health you can imagine - 0'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health.
Time frame: 6 and 12 months
HF-related mortality
Rate of HF-related mortality
Time frame: 12 months
Cardiovascular Mortality
Rate of cardiovascular mortality
Time frame: 12 months
All-cause Mortality
Rate of all-cause mortality
Time frame: 12 months
Unplanned HF-related hospitalizations
Rate of HF-related hospitalisations
Time frame: 12 months
Unplanned cardiovascular-related hospitalizations
Rate of cardiovascular-related hospitalisations
Time frame: 12 months
Unplanned all-cause hospitalizations
Rate of all-cause hospitalisations
Time frame: 12 months
Unplanned hospitalizations, other
Number of days alive and out of hospital
Time frame: 12 months
Non-serious Adverse Events
Rate of non-serious adverse events
Time frame: 12 months
Serious Adverse Events
Rate of serious adverse events
Time frame: 12 months
Symptoms of heart failure
Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score
Time frame: 12 months
Longterm-mortality
All-cause death over the entire duration of the study
Time frame: From date of randomization of the first patient until date of study termination of the last patient (observation time: between 12 and up to 62 months)
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DHZC, Campus Virchow
Berlin, Germany
Praxis am Spreebogen
Berlin, Germany
Sana Klinikum Lichtenberg
Berlin, Germany
Klinikum Bielefeld
Bielefeld, Germany
Universitätsklinikum Bonn
Bonn, Germany
...and 26 more locations