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CompletedNCT04588935Updated Feb 8, 2023

Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

A Phase 2 interventional study of Bisoprolol; Perindopril; in Women With Breast Cancer, sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus. Completed at 1 site in Belarus. Open to female participants. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by State Institution "Republican Scientific and Practical Center" Cardiology, Belarus · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
Female
01

Study summary

To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Read the detailed description

Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

02

Conditions studied

  • Women With Breast Cancer
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.

Exclusion criteria

Exclusion Criteria:

  • presence of other oncological diseases
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • No intervention
    Group 1

    women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, untreated

  • Active comparator
    Group 2

    women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy, receiving treatment with a combination of bisoprolol and perindopril

    Drug: Bisoprolol; Perindopril;

Interventions

  • DrugBisoprolol; Perindopril;

    based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed

    Also known as: Bisoprolol; Perindopril

05

What researchers measure

Primary outcomes

  1. development of cardiovascular diseases and complications

    hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure

    Time frame: 4 years

06

Study locations

1 site
  • Scientific and Practice Center of Cardiology
    Minsk, 220000, Belarus
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04588935
Lead sponsor
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
Responsible party
Dr. Chernyak Sergey (Researcher, Hypertension Laboratory Republican Scientific and Clinical Cardiology Center Republic of Belarus, Belarus, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus) — Principal investigator
First posted
Oct 19, 2020
Start date
Jul 1, 2019
Primary completion
Feb 7, 2023
Completion
Feb 7, 2023
Last update
Feb 8, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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