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CompletedNCT04875923CURE-FrailtyUpdated Mar 19, 2024

Cardiac Surgery as a Means of Reversing Frailty

An observational study in Frailty, sponsored by Dr. Valerie-Anna Rudas. Completed at 1 site in Austria. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Dr. Valerie-Anna Rudas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
60 Years and older
Sex
All
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Study summary

Frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. Key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion.

When selecting patients for surgery, frailty can play an important part in resource planning and prognostication. Multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. Despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery.

Cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty.

This prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes.

The primary endpoint of this study is the change in postoperative level of frailty.

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Conditions studied

  • Frailty

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Keywords

  • Frailty
  • Cardiac Surgery
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 80 is below the median of 223 across 496 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

This is the only study on the registry with Dr. Valerie-Anna Rudas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing an elective cardiac surgical intervention

Inclusion criteria

  • age ≥ 60 years
  • elective cardiac surgery

Exclusion criteria

Exclusion Criteria:

  • age \< 60 years
  • emergency procedures
  • pulmonary thromboendarterectomy
  • declined informed consent
  • pregnant women
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Change in Postoperative Level of Frailty

    The "Clinical Frailty Scale" (CFS) will be used to assess frailty. A CFS of 1 indicates absence of frailty, whereas a CFS of 9 indicates severe frailty. A postoperative change in the CFS indicates a postoperative change in frailty.

    Time frame: 12 months

Secondary outcomes

  1. Quality of Life assessed by the "SF-12 Patient Questionnaire"

    Quality of Life will be assessed using the SF-12 Patient Questionnaire.

    Time frame: 12 months

  2. Functional Status assessed by the "Functional Independence Measure"

    Functional status will be assessed using the "Functional Independence Measure", with lower scores indicating a worse functional status.

    Time frame: 12 months

  3. 30-day Mortality

    Number of participants who have died within 30 days postoperatively.

    Time frame: 30 days

  4. Overall Mortality

    Number of participants who have died within the study period.

    Time frame: 12 months

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Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04875923
Lead sponsor
Dr. Valerie-Anna Rudas
Responsible party
Dr. Valerie-Anna Rudas (Resident Dept. of Anesthesia, Critical Care and Pain Medicine, Medical University of Vienna) — Sponsor-investigator
First posted
May 6, 2021
Start date
Apr 9, 2021
Primary completion
Sep 28, 2022
Completion
Sep 28, 2022
Last update
Mar 19, 2024

Study contacts

Martin Bernardi, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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