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Frail Elderly SyndromeFRAIL-HEARTNCT03913299

Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery

An observational study of Frail Elderly Syndrome and Frailty, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Frail Elderly Syndrome, Frailty, Surgery
How many people
2,080 participants
Where
3 sitesBelgium
Study dates
23 Apr 2019to 30 Sep 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: All consecutive patients older than 18 years of age admitted for cardiac surgery or vascular surgery in Cliniques Universitaires Saint-Luc in Brussels will be included.

Who may be able to join

  • Any cardiac surgery under cardiopulmonary bypass
  • Any vascular surgery

Who cannot join

  • Salvage surgery
  • Cirrhosis CHILD B or C

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • St Luc University Hospital UCLouvain

    Brussels

  • Grand Hopital Charleroi

    Charleroi, 6060

  • Centre Hospitalier Universitaire de Liège

    Liège, 4000

Other trials in Belgium

About this study

Official title: Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery "Frail Heart" Study.

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

Read the detailed description

Frailty is a state of loss of functional reserve resulting in an increased vulnerability to a stressor event. From a pathophysiological point of view, it is an accelerated decrease in physiological reserve related to ageing.

Currently, evaluation of the outcome after cardiac surgery is commonly based on scores not taking into account the concept of frailty (Society of Thoracic Surgeons (STS) and Eurosore II) Recent studies have shown an independent association between post cardiac surgery mortality and pre-operative frailty. Beyond cardiac surgery, frailty has been shown to be associated with higher mortality and morbidity among intensive care unit (ICU) patients. Frailty is commonly assessed for patients older than 75 years of age but the prevalence in younger patients admitted to the hospital is significant. There is therefore need to evaluate all patients for frailty in the preoperative period.

Since the Edmonton Frail Scale (EFS) allows easy screening of all frailty domains, we hypothesized that it could be a reliable and feasible score to assess preoperative frailty and to predict postoperative morbidity and mortality.

Objectives:

The primary objective of this study is to evaluate preoperative frailty in all adult patients undergoing cardiac and vascular surgery.

The secondary objectives are:

  • to evaluate the association between frailty and postoperative mortality.
  • to evaluate the association between frailty and postoperative functional decline (nursing home admission or care dependency)
  • to evaluate impact of each frailty domain on the post-operative outcomes (mortality and functional decline)
  • to evaluate how to integrate frailty with the others preoperative clinical parameters to better predict postoperative outcome

Measurement:

Assessment of frailty will be performed using EFS. Other clinical conditions related to frailty will be collected: Body Mass Idex (BMI), tobacco use, alcohol consumption, preoperative albumin and pre-albumin level. STS and Eurosore II will be systematically calculated.

A one-year follow-up will assess the following parameters:

  • all-cause mortality
  • functional decline with admission to a nursing home or care dependency. Care dependency will be defined by a Katz index more than 0 [19].

Follow-up will be realized by a phone call to the patient, his relatives or his general practitioner.

Based on a prevalence of frailty of 11%, we have determined that the enrollment of a minimum of 2080 patients would provide a power of 80% at a significance level of 5% to detect a difference of 5% mortality at one year between frail and non-frail patients.

Keywords
Frailty, Cardiac surgery, Vascular surgery
Medical subject headings
Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: 1 year

  2. Functionnal decline

    Admission to a nursing home (yes or no) or care dependency (defined by a Katz index higher than 0/6)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start23 Apr 2019
  3. Primary completion1 Apr 2025
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,080 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913299
Sponsor's protocol ID
Frail Heart
Other IDs
2019/26FEV/094
Acronym
FRAIL-HEART
Status last verified
Apr 2025
First submitted
11 Apr 2019
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245

  • Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

    PubMed 15031310

  • Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29.

    PubMed 22378855

  • Anderson RP. First publications from the Society of Thoracic Surgeons National Database. Ann Thorac Surg. 1994 Jan;57(1):6-7. doi: 10.1016/0003-4975(94)90355-7. No abstract available.

    PubMed 8279920

  • Sundermann S, Dademasch A, Praetorius J, Kempfert J, Dewey T, Falk V, Mohr FW, Walther T. Comprehensive assessment of frailty for elderly high-risk patients undergoing cardiac surgery. Eur J Cardiothorac Surg. 2011 Jan;39(1):33-7. doi: 10.1016/j.ejcts.2010.04.013.

    PubMed 20627611

  • Bagshaw SM, Stelfox HT, Johnson JA, McDermid RC, Rolfson DB, Tsuyuki RT, Ibrahim Q, Majumdar SR. Long-term association between frailty and health-related quality of life among survivors of critical illness: a prospective multicenter cohort study. Crit Care Med. 2015 May;43(5):973-82. doi: 10.1097/CCM.0000000000000860.

    PubMed 25668751

  • Ferrante LE, Pisani MA, Murphy TE, Gahbauer EA, Leo-Summers LS, Gill TM. The Association of Frailty With Post-ICU Disability, Nursing Home Admission, and Mortality: A Longitudinal Study. Chest. 2018 Jun;153(6):1378-1386. doi: 10.1016/j.chest.2018.03.007. Epub 2018 Mar 17.

    PubMed 29559308

  • Le Maguet P, Roquilly A, Lasocki S, Asehnoune K, Carise E, Saint Martin M, Mimoz O, Le Gac G, Somme D, Cattenoz C, Feuillet F, Malledant Y, Seguin P. Prevalence and impact of frailty on mortality in elderly ICU patients: a prospective, multicenter, observational study. Intensive Care Med. 2014 May;40(5):674-82. doi: 10.1007/s00134-014-3253-4. Epub 2014 Mar 21.

    PubMed 24651884

  • Muscedere J, Waters B, Varambally A, Bagshaw SM, Boyd JG, Maslove D, Sibley S, Rockwood K. The impact of frailty on intensive care unit outcomes: a systematic review and meta-analysis. Intensive Care Med. 2017 Aug;43(8):1105-1122. doi: 10.1007/s00134-017-4867-0. Epub 2017 Jul 4.

    PubMed 28676896

  • Smart R, Carter B, McGovern J, Luckman S, Connelly A, Hewitt J, Quasim T, Moug S. Frailty Exists in Younger Adults Admitted as Surgical Emergency Leading to Adverse Outcomes. J Frailty Aging. 2017;6(4):219-223. doi: 10.14283/jfa.2017.28.

    PubMed 29165541

  • Bagshaw M, Majumdar SR, Rolfson DB, Ibrahim Q, McDermid RC, Stelfox HT. A prospective multicenter cohort study of frailty in younger critically ill patients. Crit Care. 2016 Jun 6;20(1):175. doi: 10.1186/s13054-016-1338-x.

    PubMed 27263535

  • Brummel NE, Bell SP, Girard TD, Pandharipande PP, Jackson JC, Morandi A, Thompson JL, Chandrasekhar R, Bernard GR, Dittus RS, Gill TM, Ely EW. Frailty and Subsequent Disability and Mortality among Patients with Critical Illness. Am J Respir Crit Care Med. 2017 Jul 1;196(1):64-72. doi: 10.1164/rccm.201605-0939OC.

    PubMed 27922747

  • Sundermann S, Dademasch A, Rastan A, Praetorius J, Rodriguez H, Walther T, Mohr FW, Falk V. One-year follow-up of patients undergoing elective cardiac surgery assessed with the Comprehensive Assessment of Frailty test and its simplified form. Interact Cardiovasc Thorac Surg. 2011 Aug;13(2):119-23; discussion 123. doi: 10.1510/icvts.2010.251884. Epub 2011 Mar 4.

    PubMed 21378017

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PubMed 16129869

  • Rolfson DB, Majumdar SR, Tsuyuki RT, Tahir A, Rockwood K. Validity and reliability of the Edmonton Frail Scale. Age Ageing. 2006 Sep;35(5):526-9. doi: 10.1093/ageing/afl041. Epub 2006 Jun 6. No abstract available.

    PubMed 16757522

Questions about this trial

What is this clinical trial studying?

An observational study of Frail Elderly Syndrome and Frailty, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 1 year). The study lists 2 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 NCT03913299, which also lists 18 linked publications.

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 15 Apr 2025.

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