Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Doxorubicin Induced Cardiomyopathy Clinical Trial

Official title:

Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792293
• Other study ID #: FMASUMD45/2021
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2023
• Source: Ain Shams University
• Contact: Ahmed L Mohamed, Master
• Phone: +201141141677
• Email: Doc.ahmedlotfy91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

Description:

The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy. They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo. Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines

Exclusion Criteria:

• Patients with impaired LV systolic function (EF below 50%)
• Patients with severe valvular heart disease
• Patients previously diagnosed with coronary artery disease
• Patients with baseline elevated liver enzymes
• Patients with prior chemotherapy or radiation therapy
• Pregnant females

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiotoxicity
• Doxorubicin Induced Cardiomyopathy

Intervention

Drug:
• Atorvastatin 40 Mg Oral Tablet
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cancer therapy related cardiac dysfunction among the two groups	cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography	Six months
Secondary	Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups		Six months
Secondary	Changes in left ventricular volumes assessed by 3D echocardiography among the two groups		Six months
Secondary	Changes in left ventricular diastolic function among the two groups		Six months