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| Name | Class |
|---|---|
| The German Heart Foundation | OTHER |
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Feasibility and Comparison of the Impact of different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation in advanced heart failure patients
Comparison of the feasibility and results of the following frailty assessment tools in advanced heart failure patients treated with ventricular assist device Implantation or awaiting heart transplantation in Eurotransplant-Status "high urgency":
The assessment will be conducted prior to surgery, after surgery and at 6 Month Follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplantation | Active Comparator | Frailty assessment before, after and 6 month after surgery |
|
| VAD Implantation | Active Comparator | Frailty assessment before, after and 6 month after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frailty Assessment | Diagnostic Test | Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety) | Number of patients, who were not able to perform tests and reasons | Pre-operative measurements, |
| Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety) | Number of patients, who were not able to perform tests and reasons | post-operative measurements in the week before discharge (average 4 weeks) |
| Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety) | Number of patients, who were not able to perform tests and reasons | 6 Month Follow-up |
| Impact of frailty estimated by the different frailty assessment tools on the outcome 6 month mortality and/or prolonged ventilation time | Combined Endpoint: Endpoint is met if the Patient dies within 6 month after surgery and/or needed of a prolonged ventilation time of >95h during the ICU stay after surgery | After 6 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Felix Schoenrath, MD | Contact | 00493045932085 | schoenrath@dhzb.de | |
| Luise Roehrich | Contact | 00493045932285 | roehrich@dhzb.de |
| Name | Affiliation | Role |
|---|---|---|
| Felix Schoenrath, MD | German Heart Center Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Heart Center | Recruiting | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34994094 | Derived | Roehrich L, Sundermann SH, Just IA, Kopp Fernandes L, Stein J, Solowjowa N, Mulzer J, Mueller M, Hummel M, Knierim J, Potapov E, Falk V, Schoenrath F. Comparison of feasibility and results of frailty assessment methods prior to left ventricular assist device implantation. ESC Heart Fail. 2022 Apr;9(2):1038-1049. doi: 10.1002/ehf2.13764. Epub 2022 Jan 6. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |