Comparison of Different Frailty Assessment Tools

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222400
• Other study ID #: FrailtyVAD-Tx
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: October 2020

Study information

• Verified date: January 2020
• Source: German Heart Institute
• Contact: Felix Schoenrath, MD
• Phone: 00493045932085
• Email: schoenrath[@]dhzb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Heart Failure

Intervention

Diagnostic Test:
• Frailty Assessment
Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT

Locations

Country	Name	City	State
Germany	German Heart Center	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	The German Heart Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,
Primary	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)
Primary	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
Primary	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