Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines (PEP-NAT-B)
September 10, 2025 updated by: Institut Bergonié
Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer.
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring.
In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy.
Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines.
The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes.
The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises.
Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency.
To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring.
In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy.
Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines.
The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes.
In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes.
In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received.
The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises.
Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency.
To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aquitaine
-
Bordeaux, Aquitaine, France, 33000
- Institut Bergonie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women over 18 years with effective contraceptive method (if applicable)
- NT-proBNP <125 pg / ml
- ASA 1 or 2,
- Breast cancer histologically proven
- Mastectomy or lumpectomy
- Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines,
- Patients who received the briefing and signed the informed consent
- Patients affiliated to a social security system.
Exclusion Criteria:
- Patients for whom the maintenance of general anesthesia does not use halogenated.
- Renal impairment: Creatinine clearance <60 ml / min,
- Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
- Presence of a cardiopathy
- Pregnant Women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Participants not previously treated with anthracyclines
No anthracycline treatment in the 6 months prior to inclusion.
|
NT-proBNP concentration assessed at the following time points :
|
|
Other: Participants previously treated with anthracyclines
|
NT-proBNP concentration assessed at the following time points :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-operative Concentration of NT-proBNP
Time Frame: Before breast surgery
|
Mean concentration of NT-proBNP measured before surgery.
|
Before breast surgery
|
|
Concentration of NT-proBNP at the End of Intervention
Time Frame: At the end of breast surgery
|
Mean concentration of NT-proBNP measured at the end of intervention
|
At the end of breast surgery
|
|
Post-operative Concentration of NT-proBNP
Time Frame: 24 hours after breast surgery
|
Mean concentration of NT-proBNP measured 24 hours after breast surgery
|
24 hours after breast surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer
Time Frame: 3 years
|
Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: GEKIERE Jean Pierre, MD, Institut Bergonie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
November 6, 2012
First Submitted That Met QC Criteria
December 18, 2012
First Posted (Estimated)
December 21, 2012
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 10, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IB2009-39
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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