Trial document




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  DRKS00025449

Trial Description

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Title

Association of frailty phenotypes with peri-/postoperative outcomes and gene expression in older patients with cardiovascular diseases.

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Trial Acronym

FrACoG

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URL of the Trial

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Brief Summary in Lay Language

Often, limitations in physical functionality, cognitive performance and poor nutrition are signs of a higher risk of frailty, especially in older patients.
The aim of the study is to analyze the relationship between frailty phenotypes and peri-/postoperative or peri-/postinterventional complications after cardiac surgery or transchateter aortic valve implantations (TAVI) in older (≥ 70 years) patients.
In addition, the correlation of the muscle's gene expression with the frailty status will be investigated.

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Brief Summary in Scientific Language

Peri- and postoperative complication rates are associated with the degree and severity of frailty (phenotypes, defined as impairment of the physical, cognitive and nutritional components or a combination of them) in elderly patients undergoing cardiac surgery or intervention. Furthermore, the degree of frailty status will be correlated with an alteration in the expression of specific genes in muscle in this population.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00025449
  •   2021/06/07
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  •   yes
  •   Approved
  •   EA4/086/21, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Patients undergoing cardiac surgery or elective transchateter aortic valve intervention (TAVI)
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Interventions/Observational Groups

  •   Patients undergoing elective heart surgery or intervention (TAVI) of ≥ 70 years. Immediately after the routine examinations (hospital admission), the following tests, which are not part of the clinical routine, will be carried out:
    Functional tests:
    - Handgrip strength measurement
    - Time Up-and-Go Test (TUG)
    - Walking speed (5-meter walk test)

    Bioelectrical Impedance Analysis (BIA)

    Questionnaires:
    - Basic activity of daily living (BADL; Katz index)
    - Instrumental Activity of Daily Living (IADL; Lawton Index)
    - Mini Nutritional Assessment short form (MNA-SF)
    - Mini-Mental State Examination (MMSE)
    - Cardiac anxiety questionnaire (HAF-17)
    - Health questionnaire for patients (PHQ-9)
    - Quality of life (SF-12)

    Frailty Index and Sarcopenia:
    - Bern scale
    - Sarcopenia (defined as a low skeletal muscle index and low hand strength according to the recommendations of EWGSOP2)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Mortality or major morbidity

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Secondary Outcome

Myocardial infarction,
Atrial fibrillation,
Bleeding,
Blood transfusion,
Vascular complications (access point / access-related complications),
Lung infection,
Acute respiratory distress syndrome (ARDS),
Length of stay (date; intensive care unit; hospital),
Intra-aortic balloon pump (IABP),
Pericardial effusion (need for treatment),
Delirium (need for drug treatment)
Gene expression muscles (quantitative),
Discharge to care facility or similar,
Quality of life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/06/06
  •   80
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients undergoing elective heart surgery or intervention (TAVI), age ≥ 70 years

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Exclusion Criteria

Severe cognitive impairment (e.g. diagnosed dementia)
Clinical instability (e.g. unstable vital signs),
Dialysis,
Liver cirrhosis,
Untreated cancer or life expectancy <1 year,
Oxygen demand (at home),
Need for emergency surgery / intervention,
Language barrier,
Patient's withdrawal

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Addresses

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    • Professur für Rehabilitationsmedizin, Fakultät für Gesundheitwissenschaften Brandenburg an der Universität Potsdam
    • Mr.  Prof. Dr. med.  Heinz  Völler 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • Germany
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    • Professur für Rehabilitationsmedizin, Fakultät für Gesundheitwissenschaften an der Universität Potsdam
    • Ms.  Dr.  Annett  Salzwedel 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • Germany
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    • Charité – Universitätsmedizin Berlin Klinik für Kardiovaskuläre Chirurgie
    • Mr.  PD Dr. med.  Simon  Sündermann 
    • Augustenburger Platz 1 13353 Berlin
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Professur für Rehabilitationsmedizin, Fakultät für Gesundheitwissenschaften Brandenburg an der Universität Potsdam
    • Mr.  Prof. Dr. med.  Heinz  Völler 
    • Am Neuen Palais 10, Haus 12
    • 14469  Potsdam
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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