Heart FailureNCT04222400
Comparison of Different Frailty Assessment Tools
A study testing Frailty Assessment in people with Heart Failure, run by German Heart Institute at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Frailty Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2018to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
- Signature on Informed Consent
Who cannot join
- < 18 years old
- Informed consent not possible/not signed
- Pregnancy/Breastfeeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Heart Center
Berlin, 13353
Felix Schoenrath, MD, 00493045932085, schoenrath@dhzb.de
About this study
Official title: 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
Read the 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
- Conditions
- Heart Failure
- Being tested
- Frailty Assessment
- Keywords
- Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass
- Medical subject headings
- Heart Failure, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frailty AssessmentDiagnostic test
Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT
| Study group | Role | What they receive |
|---|---|---|
| Transplantation | Active comparator | Frailty assessment before, after and 6 month after surgery Receives: Diagnostic Test: Frailty Assessment |
| VAD Implantation | Active comparator | Frailty assessment before, after and 6 month after surgery Receives: Diagnostic Test: Frailty Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: After 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start15 Mar 2018
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Felix Schoenrath, MD, Principal investigator, German Heart Center Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222400
- Sponsor's protocol ID
- FrailtyVAD-Tx
- Status last verified
- Jan 2020
- First submitted
- 8 Aug 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34994094
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Comparison of the Impact of Different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation
- ClinicalTrials.gov ID
- NCT04222400
- Acronym / sponsor ID
- FrailtyVAD-Tx
- Conditions
- Heart Failure
- Keywords
- Advanced Heart Failure, Ventricular Assist Device, Heart Transplantation, Frailty, Sarcopenia, Bioelectrical Impedance Analysis, Muscle Mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- The German Heart Foundation
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplantation | Active comparator | Diagnostic Test: Frailty AssessmentFrailty assessment before, after and 6 month after surgery |
| VAD Implantation | Active comparator | Diagnostic Test: Frailty AssessmentFrailty assessment before, after and 6 month after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
- Signature on Informed Consent
Key exclusion criteria (3 listed)
- < 18 years old
- Informed consent not possible/not signed
- Pregnancy/Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frailty AssessmentBioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT | Diagnostic test | Transplantation, VAD Implantation |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 34994094Roehrich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Schoenrath, MD principal investigator
German Heart Center Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frailty Assessment in people with Heart Failure, run by German Heart Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felix Schoenrath, MD (00493045932085, schoenrath@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety) (time frame: Pre-operative measurements,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.