Comparison of Different Frailty Assessment Tools

Study Overview
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Brief Summary
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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

Detailed Description
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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: Evaluation of the muscle mass in the preoperative CT-Scan Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Measurement Questionnaires: EQ5D-5L, Rockwood Frailty Scale The assessment will be conducted prior to surgery, after surgery and at 6 Month Follow-up

Official Title
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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

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Frailty Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned VAD Implantation/ HU-Status awaiting Heart Transplantation Signature on Informed Consent Exclusion Criteria: < 18 years old Informed consent not possible/not signed Pregnancy/Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transplantation<br>Frailty assessment before, after and 6 month after surgery | Diagnostic Test: Frailty Assessment<br>* Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT<br>|
| Active Comparator: VAD Implantation<br>Frailty assessment before, after and 6 month after surgery | Diagnostic Test: Frailty Assessment<br>* Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass