Comparison of Different Frailty Assessment Tools

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04222400

Enrollment

150

Registered

2020-01-10

Start date

2018-03-15

Completion date

2020-10-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass

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

Interventions

DIAGNOSTIC_TESTFrailty Assessment

Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)	Pre-operative measurements,	Number of patients, who were not able to perform tests and reasons

Countries

Germany

Contacts

Primary ContactFelix Schoenrath, MD

schoenrath@dhzb.de00493045932085

Backup ContactLuise Roehrich

roehrich@dhzb.de00493045932285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026