Comparison of Different Frailty Assessment Tools

Not Applicable

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Frailty Assessment

• Registration Number: NCT04222400
• Lead Sponsor: German Heart Institute

Brief Summary

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

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

Study Timeline

• Study Start: 2018-03-15
• Study First Submitted: 2019-08-08
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-10
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VAD Implantation	Frailty Assessment	Frailty assessment before, after and 6 month after surgery
Transplantation	Frailty Assessment	Frailty assessment before, after and 6 month after surgery

Primary Outcome Measures

Name	Time	Method
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)	6 Month Follow-up	Number of patients, who were not able to perform tests and reasons
Impact of frailty estimated by the different frailty assessment tools on the outcome 6 month mortality and/or prolonged ventilation time	After 6 Month	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

Trial Locations

Locations (1)

German Heart Center; 🇩🇪 Berlin, Germany