Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery (B-BIT)

12. Mai 2026 aktualisiert von: Chang-Ik Yoon

A Pragmatic Clinical Trial to Evaluate the Impact of Clinical Propranolol Strategies on Myocardial Injury After Non-cardiac Surgery (MINS) in Patients Undergoing Breast Cancer Surgery With Hypertension or Angina

This study aims to evaluate the impact of using propranolol, a non-selective beta-blocker, on preventing myocardial injury after non-cardiac surgery (MINS) in breast cancer patients who also have hypertension or angina. Stress from surgery and anesthesia can increase sympathetic activity and inflammation, which may lead to heart stress. This pragmatic clinical trial will compare patients who are prescribed propranolol as part of their routine care with those who are not. Researchers will analyze blood samples and surgical tissues collected during normal treatment to observe changes in heart health and the tumor microenvironment.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Breast cancer is the most common malignancy among women in Korea. Perioperative stress and acute physiological stimuli from surgery and anesthesia increase catecholamine secretion, which can lead to Myocardial Injury after Non-cardiac Surgery (MINS). Propranolol is known to stabilize hemodynamic variability by inhibiting sympathetic surge and reducing myocardial oxygen consumption. Recent studies also suggest that beta-blockers may influence the tumor microenvironment (TME) by reducing inflammation and regulating immune cell composition.This prospective, randomized, open-label, single-center pragmatic clinical trial will enroll 100 female patients (aged 20-70) with stage I-III breast cancer and comorbid hypertension or angina. Participants will be randomized 1:1 into two groups:

  1. Propranolol Group: Patients receive propranolol for at least 14 days before surgery.
  2. Non-Propranolol Group: Patients receive usual care without propranolol.The primary objective is to compare the incidence of MINS based on high-sensitivity Troponin T (hs-TnT) levels measured postoperatively. Exploratory objectives include analyzing markers of inflammation (CRP, LDH), tumor proliferation (Ki-67), and tumor-infiltrating lymphocytes (TILs) using blood and tissue samples naturally obtained during the clinical process. Long-term follow-up will be conducted for up to 5 years to evaluate recurrence and survival outcomes.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Chang Ik Yoon, MD, Ph.D.
  • Telefonnummer: 82-10-8774-0103
  • E-Mail: fayn@daum.net

Studienorte

  • Südkorea
    • Seoul
      • Seoul, Seoul, Südkorea, 06591
        • Seoul St. Mary's Hospital, The Catholic University of Korea
        • Kontakt:
        • Kontakt:
          • Chang Ik Yoon, MD, Ph.D.
          • Telefonnummer: 82-10-8774-0103
          • E-Mail: fayn@daum.net

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Female patients aged 20 to 70 years.
  2. Patients diagnosed with hypertension or angina who require medication.
  3. Patients diagnosed with unilateral, resectable primary breast cancer (ICD-10: C50), Stage I-III.
  4. ECOG performance status of 0-1.
  5. Patients scheduled to receive standard postoperative treatment (including adjuvant radiotherapy
  6. Patients who voluntarily decide to participate and sign the written informed consent form

Exclusion Criteria:

  1. Patients with distant metastases.
  2. Patients with active infectious diseases, autoimmune diseases (including specific rheumatic diseases), coagulation disorders, or cardiovascular diseases other than hypertension or angina pectoris.

  3. Patients with clinically significant hepatic, hematologic, or renal dysfunction, defined as any of the following:

    ① ANC <1,500/mm3

    • Platelets <100,000/mm3

      • Hb <9 g/dL

        • AST and ALT > 2.5 x upper limit of normal (ULN) ⑤ Alkaline phosphatase > 2.5 x ULN ⑥ Total bilirubin > 1 x ULN ⑦ Serum creatinine >1.5 x ULN or estimated creatinine clearance < 60 mL/min (as calculated using the method standard for the institution)
  4. Patients with moderate to severe asthma or chronic obstructive pulmonary disease (COPD).
  5. Patients who are pregnant or breastfeeding at the time of enrollment.
  6. Patients with a history of malignancy within the past 5 years.
  7. Patients for whom data collection is considered difficult at the discretion of the investigator.
  8. Patients who are unable to understand or complete study questionnaires.
  9. Patients who have received β-blockers within 30 days prior to screening.
  10. Patients with systolic blood pressure < 100 mmHg or heart rate < 55 beats per minute.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Propranolol Group
Participants with hypertension or angina undergoing breast cancer surgery will receive Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
Arzneimittel: propranolol
Propranolol (dosage based on clinical indication) for at least 14 days before surgery until the morning of the operation.
Aktiver Komparator: Non-Propranolol Group (Usual Care)
Participants will receive standard clinical care for hypertension or angina without the use of Propranolol or other beta-blockers before surgery
Sonstiges: Usual Care
Standard medical management (e.g., CCB, ACEi, ARB, or diuretics) at the physician's discretion, excluding beta-blockers.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)
Zeitfenster: From the day of surgery (Day 0) up to 30 days postoperatively

MINS is defined as an elevated high-sensitivity cardiac Troponin T (hs-TnT) level measured for clinical purposes after surgery that exceeds the 99th percentile upper reference limit.

Specifically, it is defined as:

  1. 0.02-0.065 ng/mL with an absolute change of more than 0.005ng/mL or
  2. any elevation ≥0.065 ng/mL or any absolute change more than 0.014 ng/mL
From the day of surgery (Day 0) up to 30 days postoperatively

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Perioperative Hemodynamic Stability: Systolic Blood Pressure Fluctuation
Zeitfenster: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Comparison of the fluctuation range of blood pressure during surgery and in the recovery room (up to 2hours post-surgery)
During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Perioperative Hemodynamic Stability: Heart rate Fluctuation
Zeitfenster: During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Comparison of the fluctuation range of Heart rate during surgery and in the recovery room (up to 2hours post-surgery)
During surgery and in the recovery room (up to 2hours post-surgery)(Day 0)
Postoperative Cardiovascular and Respiratory Complications Rate
Zeitfenster: Within 30 days after surgery
Incidence of major cardiovascular and respiratory complications, including MI, CVA, MINS, and pulmonary complications.
Within 30 days after surgery
length of hospital stay
Zeitfenster: Within 30 days after surgery
Total number of days from the date of surgery to the date of discharge.
Within 30 days after surgery
Change in Patient-Reported Anxiety (HADS-A)
Zeitfenster: Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery
Evaluation of the change in anxiety levels using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The score ranges from 0 to 21, with higher scores indicating higher anxiety.
Baseline (Screening), Just before surgery (Day 0), and 6 months after surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Tumor Microenvironment and Biological Markers: Ki-67 Proliferation Index
Zeitfenster: At the time of surgery (Day 0)
The percentage of Ki-67 positive tumor cells measured by immunohistochemistry in surgical tissues.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Histological Grade
Zeitfenster: At the time of surgery (Day 0)
Assessment of tumor differentiation using the Modified Bloom-Richardson grade. The scale ranges from 3 to 9, where higher scores indicate a more aggressive tumor/worse outcome.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Presence of Lymphovascular Invasion
Zeitfenster: At the time of surgery (Day 0)
Pathological assessment of the presence or absence of tumor cells within lymphatic or vascular channels in the surgical specimen.
At the time of surgery (Day 0)
Tumor Microenvironment and Biological Markers: Tumor-Infiltrating Lymphocytes (TILs)
Zeitfenster: At the time of surgery (Day 0)
Percentage of stromal area occupied by mononuclear inflammatory cells in the surgical specimen.
At the time of surgery (Day 0)
Changes in Inflammatory Markers and Serum Tumor Markers: C-Reactive Protein (CRP)
Zeitfenster: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in C-reactive protein (CRP)
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: lactate dehydrogenase (LDH)
Zeitfenster: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in lactate dehydrogenase (LDH)
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: Carcinoembryonic Antigen (CEA)
Zeitfenster: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in serum tumor marker CEA
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Changes in Inflammatory Markers and Serum Tumor Markers: Cancer Antigen 15-3 (CA 15-3)
Zeitfenster: Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Comparison of changes in serum tumor markers CA 15-3
Baseline (Screening), Day 0 (Surgery), and 6 months after surgery
Long-term Recurrence and Survival Outcomes
Zeitfenster: Up to 5 years after surgery
Descriptive analysis of recurrence status, invasive disease-free survival (iDFS), and overall survival (OS)
Up to 5 years after surgery
Molecular and Immunological Analysis
Zeitfenster: Up to 5 years (duration of sample storage and analysis)
Exploration of biological changes related to propranolol use through molecular analysis (e.g., RNA/DNA sequencing) using stored tissue and blood samples.
Up to 5 years (duration of sample storage and analysis)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chang-Ik Yoon

Mitarbeiter

Seoul St. Mary's Hospital

Ermittler

  • Hauptermittler: Chang Ik Yoon, MD, Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

26. Mai 2026

Primärer Abschluss (Geschätzt)

23. Mai 2028

Studienabschluss (Geschätzt)

24. Mai 2033

Studienanmeldedaten

Zuerst eingereicht

27. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KC26MISV0115
  • KCT0011912 (Andere Kennung: Clinical Research Information Service)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Brustkrebs

Klinische Studien zur propranolol

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Macedonia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren