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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan. | |
| Intervention Group | Active Comparator | As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMSTM HF sensor - pulmonary artery pressure measurement | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Primary safety endpoint: device-related complications | Rate of Device / System related complications | 12 months |
| Co-primary safety endpoint: sensor failure | Rate of sensor failures | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 months |
| Changes in generic health-related quality of life |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Störk, MD | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SLK-Kliniken GmbH - Klinikum am Plattenwald | Bad Friedrichshall | 74177 | Germany | |||
| Kerckhoff-Klinik Forschungs GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35246723 | Background | Stork S, Bernhardt A, Bohm M, Brachmann J, Dagres N, Frantz S, Hindricks G, Kohler F, Zeymer U, Rosenkranz S, Angermann C, Assmus B. Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial. Clin Res Cardiol. 2022 Nov;111(11):1245-1255. doi: 10.1007/s00392-022-01987-3. Epub 2022 Mar 4. |
| Label | URL |
|---|---|
| The Gemeinsamer Bundesausschuss as commissioner of the clinical study describes the scientific background and organisation of the trial German only) | View source |
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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. |
| 6 and 12 months |
| HF-related mortality | Rate of HF-related mortality | 12 months |
| Cardiovascular Mortality | Rate of cardiovascular mortality | 12 months |
| All-cause Mortality | Rate of all-cause mortality | 12 months |
| Unplanned HF-related hospitalizations | Rate of HF-related hospitalisations | 12 months |
| Unplanned cardiovascular-related hospitalizations | Rate of cardiovascular-related hospitalisations | 12 months |
| Unplanned all-cause hospitalizations | Rate of all-cause hospitalisations | 12 months |
| Unplanned hospitalizations, other | Number of days alive and out of hospital | 12 months |
| Non-serious Adverse Events | Rate of non-serious adverse events | 12 months |
| Serious Adverse Events | Rate of serious adverse events | 12 months |
| Symptoms of heart failure | Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score | 12 months |
| Longterm-mortality | All-cause death over the entire duration of the study | 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) |
| 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 |
| DHZC, Campus Virchow | Berlin | Germany |
| Praxis am Spreebogen | Berlin | Germany |
| Sana Klinikum Lichtenberg | Berlin | Germany |
| Klinikum Bielefeld | Bielefeld | Germany |
| Universitätsklinikum Bonn | Bonn | Germany |
| Klinikum Coburg | Coburg | Germany |
| St Johannes Hospital Dortmund | Dortmund | Germany |
| Praxisklinik Herz und Gefäße | Dresden | Germany |
| Universitäts-Herzzentrum Dresden | Dresden | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| St. Georg Klinikum | Eisenach | Germany |
| Helios Klinikum Erfurt | Erfurt | Germany |
| St. Elisabeth Krankenhaus, Contilia Herz- und Gefäßzentrum | Essen | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Klinikum Fürth | Fürth | Germany |
| Universitätsklinikum Gießen | Giessen | Germany |
| Universitäres Herz- und Gefäßzentrum Hamburg | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Westpfalz Klinikum | Kaiserslautern | Germany |
| Klinikum Karlsburg | Karlsburg | Germany |
| Leipzig Heart Institute GmbH | Leipzig | Germany |
| Cardio Centrum Ludwigsburg-Bietigheim | Ludwigsburg | Germany |
| Universitätsklinikum Magdeburg | Magdeburg | Germany |
| Klinikum Oldenburg | Oldenburg | Germany |
| Cardio Consil Rostock | Rostock | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | Germany |
| Schwarzwald-Baar Klinikum | Villingen-Schwenningen | Germany |
| Rems-Murr Klinikum | Winnenden | Germany |
| Deutsches Zentrum für Herzinsuffizienz (DZHI) | Würzburg | 97080 | Germany |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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