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

February 7, 2023 updated by: Dr. Chernyak Sergey, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

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

  • Belarus
      • Minsk, Belarus, 220000
        • Scientific and Practice Center of Cardiology

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of other oncological diseases

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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;
based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed
Other Names:
  • Bisoprolol; Perindopril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
development of cardiovascular diseases and complications
Time Frame: 4 years
hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

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 (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

February 7, 2023

Study Completion (ACTUAL)

February 7, 2023

Study Registration Dates

First Submitted

October 9, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20192755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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