Comparison of Different Frailty Assessment Tools

German Heart Institute

Status: Unknown

Conditions: Heart Failure

Treatments: Diagnostic Test: Frailty Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04222400

FrailtyVAD-Tx

Details and patient eligibility

About

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

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Transplantation

Active Comparator group

Description:

Frailty assessment before, after and 6 month after surgery

Treatment:

Diagnostic Test: Frailty Assessment

VAD Implantation

Active Comparator group

Description:

Frailty assessment before, after and 6 month after surgery

Treatment:

Diagnostic Test: Frailty Assessment