Comparison of Different Frailty Assessment Tools

January 8, 2020 updated by: German Heart Institute

Feasibility and Comparison of the Impact of Different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • German Heart Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Transplantation
Frailty assessment before, after and 6 month after surgery
Diagnostic test: Frailty Assessment
Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT
ACTIVE_COMPARATOR: VAD Implantation
Frailty assessment before, after and 6 month after surgery
Diagnostic test: Frailty Assessment
Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT

What is the study measuring?

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)
Time Frame: Pre-operative measurements,
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)
Time Frame: post-operative measurements in the week before discharge (average 4 weeks)
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)
Time Frame: 6 Month Follow-up
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
Time Frame: 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
After 6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

The German Heart Foundation

Investigators

  • Principal Investigator: Felix Schoenrath, MD, German Heart Center Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 15, 2018

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (ACTUAL)

January 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FrailtyVAD-Tx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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