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Comparison of Different Frailty Assessment Tools

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Frailty Assessment
Sponsored by
German Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Heart CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transplantation

VAD Implantation

Arm Description

Frailty assessment before, after and 6 month after surgery

Frailty assessment before, after and 6 month after surgery

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 8, 2019
Last Updated
January 8, 2020
Sponsor
German Heart Institute
Collaborators
The German Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04222400
Brief Title
Comparison of Different Frailty Assessment Tools
Official Title
Feasibility and Comparison of the Impact of Different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Heart Institute
Collaborators
The German Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transplantation
Arm Type
Active Comparator
Arm Description
Frailty assessment before, after and 6 month after surgery
Arm Title
VAD Implantation
Arm Type
Active Comparator
Arm Description
Frailty assessment before, after and 6 month after surgery
Intervention Type
Diagnostic Test
Intervention Name(s)
Frailty Assessment
Intervention Description
Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT
Primary Outcome Measure Information:
Title
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
Description
Number of patients, who were not able to perform tests and reasons
Time Frame
Pre-operative measurements,
Title
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
Description
Number of patients, who were not able to perform tests and reasons
Time Frame
post-operative measurements in the week before discharge (average 4 weeks)
Title
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
Description
Number of patients, who were not able to perform tests and reasons
Time Frame
6 Month Follow-up
Title
Impact of frailty estimated by the different frailty assessment tools on the outcome 6 month mortality and/or prolonged ventilation time
Description
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
Time Frame
After 6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Schoenrath, MD
Phone
00493045932085
Email
schoenrath@dhzb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Luise Roehrich
Phone
00493045932285
Email
roehrich@dhzb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Schoenrath, MD
Organizational Affiliation
German Heart Center Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Heart Center
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Schoenrath, MD
Phone
00493045932085
Email
schoenrath@dhzb.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34994094
Citation
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.
Results Reference
derived

Learn more about this trial

Comparison of Different Frailty Assessment Tools

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