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RecruitingNCT04014647MOBOSUpdated Jun 8, 2026

Measurement Of NT-proBNP to Predict Outcomes in Surgery

An observational study in Vascular Surgical Procedure, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

The team is investigating whether N-terminal pro B-type natriuretic peptide (NT-proBNP) and other cardiac markers are useful for predicting outcomes for patients undergoing vascular surgery. By measuring NT-proBNP before and after surgery, the investigators may be able to determine which patients are at risk of an adverse outcome, such as a heart attack or death.

Read the detailed description

Almost 1 in 5 patients who have elective major vascular surgery experience death or a myocardial infarction (MI) at 18 months post-surgery. Research has shown that peri-operative interventions may improve outcomes for high-risk patients. Cardiac bio-markers may be used to identify these high-risk patients, in particular pre- and post-operative NT-proBNP.

Mahla found that by comparing surgery outcomes with NT-proBNP concentrations peri-operatively, high-risk patients could be identified and subsequent therapeutic decisions could be made to minimise adverse outcomes.

Van Kimmenade evaluated patients with acute heart failure and found that galectin-3 (Gal-3) was the best predictor of 60-day mortality compared with NT-proBNP and apelin (another cardiac marker), whereas NT-proBNP was the most useful for diagnosing HF. The authors also found that the combination of both markers (Gal-3 and NT-proBNP) have an even higher predictive value for outcome.

The predictive role of troponin I (cTnI) has been observed in a paper by Bursi et al. (2005) where patients undergoing elective major vascular surgery were stratified using the American College of Cardiology/American Heart Association (ACC/AHA) guidelines and followed up over a period of 24 months. Patients in every group with an elevated post-operative cTnI (≥100ng/L) were at greater risk of either MI or death.

The successful identification of high-risk patients can go on to have interventional risk-reducing pharmacological, therapeutic, diagnostic, or observational measures.

Prevention of cardiovascular events, particular for an aging population, can have positive impact on both the patient and society as a whole as it may result in patients maintaining their independence, avoiding major illness, avoiding nursing home care and living longer.

02

Conditions studied

  • Vascular Surgical Procedure

Keywords

  • Vascular Surgical Procedure
  • Pro-brain natriuretic peptide (1-76)
  • Natriuretic Peptide, Brain
  • Troponin I
  • Galectin 3
  • Biomarkers
  • Risk
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have been referred to have vascular surgery

Eligibility criteria

Inclusion Criteria:

  • Patients who are equal to or over 18 years old
  • Patients scheduled to undergo elective surgery for the following procedures:
  • Infrainguinal arterial reconstruction
  • Aortic aneurysm
  • Aorto-bifemoral bypass / or aortic endarterectomy
  • Femoro-popliteal bypass
  • Femoro-distal bypass
  • Femoral endarterectomy
  • Femoro-femoral crossover
  • Axillo-femoral bypass
  • Elective carotid surgery
  • Patients having either general or regional anaesthesia for their surgery

Exclusion Criteria:-

  • Patients undergoing emergency surgery
  • Those who are unable or unwilling to give informed consent
  • Patients with unstable coronary syndromes (acute or recent MI with evidence of important ischemic risk by clinical symptoms or stress testing or unstable or severe angina pectoris)
  • Patients with decompensated heart failure (new onset shortness of breath and rales together with echocardiographic evidence of cardiac dysfunction or deterioration of chronic heart failure despite heart failure therapy)
  • Patients with chronic atrial fibrillation
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Event-free

    Patients who have had no negative events (as described in group 2)

  • Negative event

    Group 2 - patients with one or more of the following negative events post-operatively: * Whether the patient has been prescribed inotropic support * Wound infection by assessing use of antibiotics. * Length of stay in hospital \>1 week * Reduced renal function assessed by having any AKI alert during hospital stay * Cardiac event within 31 days following surgery * Death within 31 days following surgery

05

What researchers measure

Primary outcomes

  1. NT-proBNP blood test measured on the day of (pre-) vascular surgery

    NT-proBNP blood test measured on the day of (pre-) vascular surgery

    Time frame: 4 days

  2. NT-proBNP blood test measured on the day 4 after (post-) vascular surgery

    NT-proBNP blood test measured on the day 4 after (post-) vascular surgery

    Time frame: 4 days

  3. Change in NT-proBNP peri-operatively

    Change in NT-proBNP peri-operatively

    Time frame: 4 days

Secondary outcomes

  1. Pre-, post-, and peri-operative troponin I

    Pre-, post-, and peri-operative troponin I

    Time frame: 4 days

  2. Pre-, post-, and peri-operative galectin-3

    Pre-, post-, and peri-operative galectin-3

    Time frame: 4 days

  3. Pre-, post-, and peri-operative CRP

    Pre-, post-, and peri-operative CRP

    Time frame: 4 days

  4. Pre-, post-, and peri-operative creatinine

    Pre-, post-, and peri-operative creatinine

    Time frame: 4 days

06

Study locations

1 of 1 sites recruiting
  • Norfolk & Norwich University Hospitals NHS Foundation Trust
    Norwich, Norfolk NR4 7UY, United Kingdom
    Recruiting
07

References and documents

Publications

  • Augoustides J, Fleisher LA. Advancing perioperative prediction of cardiac risk after vascular surgery: does postoperative N-terminal pro-brain natriuretic peptide do the trick? Anesthesiology. 2007 Jun;106(6):1080-2. doi: 10.1097/01.anes.0000267586.04132.65. No abstract available. PubMed 17525578 ↗
  • Bursi F, Babuin L, Barbieri A, Politi L, Zennaro M, Grimaldi T, Rumolo A, Gargiulo M, Stella A, Modena MG, Jaffe AS. Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation. Eur Heart J. 2005 Nov;26(22):2448-56. doi: 10.1093/eurheartj/ehi430. Epub 2005 Jul 29. PubMed 16055493 ↗
  • Canavan M, Smyth A, Robinson SM, Gibson I, Costello C, O'Keeffe ST, Walsh T, Mulkerrin EC, O'Donnell MJ. Attitudes to outcomes measured in clinical trials of cardiovascular prevention. QJM. 2016 Jun;109(6):391-7. doi: 10.1093/qjmed/hcv132. Epub 2015 Jul 31. PubMed 26231089 ↗
  • Feringa HH, Schouten O, Dunkelgrun M, Bax JJ, Boersma E, Elhendy A, de Jonge R, Karagiannis SE, Vidakovic R, Poldermans D. Plasma N-terminal pro-B-type natriuretic peptide as long-term prognostic marker after major vascular surgery. Heart. 2007 Feb;93(2):226-31. doi: 10.1136/hrt.2006.093716. Epub 2006 Aug 16. PubMed 16914484 ↗
  • Mahla E, Baumann A, Rehak P, Watzinger N, Vicenzi MN, Maier R, Tiesenhausen K, Metzler H, Toller W. N-terminal pro-brain natriuretic peptide identifies patients at high risk for adverse cardiac outcome after vascular surgery. Anesthesiology. 2007 Jun;106(6):1088-95. doi: 10.1097/01.anes.0000267591.34626.b0. PubMed 17525582 ↗
  • van Kimmenade RR, Januzzi JL Jr, Ellinor PT, Sharma UC, Bakker JA, Low AF, Martinez A, Crijns HJ, MacRae CA, Menheere PP, Pinto YM. Utility of amino-terminal pro-brain natriuretic peptide, galectin-3, and apelin for the evaluation of patients with acute heart failure. J Am Coll Cardiol. 2006 Sep 19;48(6):1217-24. doi: 10.1016/j.jacc.2006.03.061. Epub 2006 Aug 28. PubMed 16979009 ↗
  • Yeh HM, Lau HP, Lin JM, Sun WZ, Wang MJ, Lai LP. Preoperative plasma N-terminal pro-brain natriuretic peptide as a marker of cardiac risk in patients undergoing elective non-cardiac surgery. Br J Surg. 2005 Aug;92(8):1041-5. doi: 10.1002/bjs.4947. PubMed 15997451 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04014647
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Jul 10, 2019
Start date
Sep 5, 2019
Primary completion
Sep 5, 2029 (estimated)
Completion
Sep 5, 2029 (estimated)
Last update
Jun 8, 2026

Study contacts

Emma Miler, MSc BSc Hons
Contact
emma.miler@nnuh.nhs.net
+44(0)1603-286-932
Allison Chipchase, Dr
Contact
allison.chipchase@nnuh.nhs.net
+44(0)1603-286-929
Emma Miler, MSc BSc Hons
principal investigator · principle investigator

Oversight

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

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