Bisoprolol Administration to Prevent Anthracycline-induced Cardiotoxicity

NCT05175066 | Completed Phase 3 DMC

• 1 other identifier: SamanRostambeigi
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Anthracyclines are one of the most well-known and effective drugs used to treat malignancies.The most important limiting factor in the use of this drug is its cardiac toxicity which includes cardiomyopathy and congestive heart failure. Bisoprlol is a β1-specific β-blocker that can reduce cardiac overload and also have anti-inflammatory antioxidant effects and can reduce reactive oxygen metabolites so it can be used as a cardioprotective agent in patients with a high risk of heart failure. To the best of our knowledge, no study has been performed to evaluate the prophylactic effect of bisoprolol solely in patients under chemotherapy with anthracyclines. This study is aimed to evaluate the cardioprotective role of bisoprolol in patients with non-metastatic breast cancer receiving doxorubicin, by measuring global longitudinal strain before and after treatment.

Conditions

Cardiomyopathies; Chemotherapy Effect; Diastolic Dysfunction; Systolic Dysfunction

Keywords

Bisoprolol; Cardiomyopathy; Chemotherapy; Anthracyclines

Outcome Measures

Primary Outcomes (2)

• LVEF

  Change in Left ventricular ejection-fraction after chemotherapy

  Baseline and after 6 months

• GLS

  Change in global longitudinal strain after chemotherapy

  Baseline and after 6 months

Secondary Outcomes (1)

• Diastolic dysfunction

  Baseline and after 6 months

Study Arms (2)

Bisoprolol

EXPERIMENTAL

40 patients who were given bisoprolol at a dose of 1.25 mg daily, and in the absence of clinical symptoms and heart rate above 60 and systolic blood pressure above 100, 1.25 mg was added to the therapeutic dose every 2 weeks to reach 5 mg daily.

Drug: Bisoprolol

Placebo

PLACEBO COMPARATOR

Two placebo tablets in similar shape and color to bisoprolol were given on a daily basis to each of the 40patients as the control group.

Drug: Placebo

Interventions

Bisoprolol DRUG

For patients who were candidates to start therapy with anthracycline, bisoprolol was administrated as explained before to determine the effect of this drug on the reduction of anthracycline-induced cardiomyopathy.

Bisoprolol

Placebo DRUG

Tablets with similar shape and size and color to bisoprolol were given to the patients whom undergone chemotherapy with anthracyclines to compare the effects between two groups.

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Women with Non-metastatic breast cancer that undergone Anthracyclin-based chemotherapy regimen
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients that was diagnosed with non-metastatic breast cancer and anthracycline-based chemotherapy were planned for them

You may not qualify if:

• Established ischemic heart disease
• Baseline LVEF \<50%, cardiomyopathy (restrictive, dilated or hypertrophic) detected by transthoracic echocardiography
• Moderate or severe valvular disease,
• Prior chemotherapy,
• Presence of contraindication for beta-blockers and cardiac arrhythmias and lack of patient compliance
• Patients that had consuming angiotensin converting enzyme Inhibitors, angiotensin receptor Inhibitors,diuretics,statins,other beta-blockers or non-dihydropyridin calcium channel blockers

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Rasool Akram hospital

Tehran, 1995614331, Iran

Location

Related Publications (2)

• Tashakori Beheshti A, Mostafavi Toroghi H, Hosseini G, Zarifian A, Homaei Shandiz F, Fazlinezhad A. Carvedilol Administration Can Prevent Doxorubicin-Induced Cardiotoxicity: A Double-Blind Randomized Trial. Cardiology. 2016;134(1):47-53. doi: 10.1159/000442722. Epub 2016 Feb 12.

  PMID: 26866364 BACKGROUND

• Silber JH, Cnaan A, Clark BJ, Paridon SM, Chin AJ, Rychik J, Hogarty AN, Cohen MI, Barber G, Rutkowski M, Kimball TR, Delaat C, Steinherz LJ, Zhao H. Enalapril to prevent cardiac function decline in long-term survivors of pediatric cancer exposed to anthracyclines. J Clin Oncol. 2004 Mar 1;22(5):820-8. doi: 10.1200/JCO.2004.06.022.

  PMID: 14990637 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 3, 2022
• Study Start: November 12, 2020
• Primary Completion: October 7, 2021
• Study Completion: December 2, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From February 2022
• Access Criteria: Everyone with verified institutional email.

Locations

IR (1)