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

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ClinicalTrials.gov Identifier: NCT04588935
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Chernyak Sergey, State Institution "Republican Scientific and Practical Center" Cardiology, Belarus

Brief 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

Condition or disease Intervention/treatment Phase
Women With Breast Cancer Drug: Bisoprolol; Perindopril; Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: To Develop and Implement a Method for Medical Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2024


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 Name: Bisoprolol; Perindopril




Primary Outcome Measures :
  1. development of cardiovascular diseases and complications [ Time Frame: 4 years ]
    hypertension, cardiomyopathy, arrhythmia's, myocardial infarction, heart failure



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • presence of other oncological diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588935


Contacts
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Contact: Sergey Chernyak +375296322661 Lapydus@yandex.ru

Locations
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Belarus
Scientific and Practice Center of Cardiology Recruiting
Minsk, Belarus, 220000
Contact: Olga Pavlova       olga.s_pavlova@yahoo.com   
Contact: Sergey Charnyak    +375296322661    Lapydus@yandex.ru   
Sponsors and Collaborators
State Institution "Republican Scientific and Practical Center" Cardiology, Belarus
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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
ClinicalTrials.gov Identifier: NCT04588935    
Other Study ID Numbers: 20192755
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiovascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bisoprolol
Perindopril
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors