NCT04222400

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

August 8, 2019

Last Update Submit

January 8, 2020

Conditions

Heart Failure

Keywords

Advanced Heart FailureVentricular Assist DeviceHeart TransplantationFrailtySarcopeniaBioelectrical Impedance AnalysisMuscle Mass

Outcome Measures

Primary Outcomes (4)

  • 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,

  • 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)

  • 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

  • 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

Study Arms (2)

Transplantation

ACTIVE COMPARATOR

Frailty assessment before, after and 6 month after surgery

Diagnostic Test: Frailty Assessment

VAD Implantation

ACTIVE COMPARATOR

Frailty assessment before, after and 6 month after surgery

Diagnostic Test: Frailty Assessment

Interventions

Frailty AssessmentDIAGNOSTIC_TEST

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

TransplantationVAD Implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
  • Signature on Informed Consent

You may not qualify if:

  • \< 18 years old
  • Informed consent not possible/not signed
  • Pregnancy/Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Center

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34994094DERIVED

MeSH Terms

Conditions

Heart FailureFrailtySarcopenia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Felix Schoenrath, MD

    German Heart Center Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Schoenrath, MD

CONTACT

00493045932085schoenrath@dhzb.de

Luise Roehrich

CONTACT

00493045932285roehrich@dhzb.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

January 10, 2020

Study Start

March 15, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)