Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05792293

Enrollment

100

Registered

2023-03-31

Start date

2021-06-01

Completion date

2023-06-30

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doxorubicin Induced Cardiomyopathy

Keywords

Anthracyclines, Doxorubuicn, Cardiotoxicity

Brief summary

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

Detailed 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.

Interventions

DRUGAtorvastatin 40 Mg Oral Tablet

40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

Single blind

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of cancer therapy related cardiac dysfunction among the two groups	Six months	cancer therapy related cardiac dysfunction defined as drop in ejection fraction more than 10% and to a value below 53% assessed by 3D echocardiography

Secondary

Measure	Time frame
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups	Six months
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups	Six months
Changes in left ventricular diastolic function among the two groups	Six months

Countries

Egypt

Contacts

Primary ContactAhmed L Mohamed, Master

Doc.ahmedlotfy91@gmail.com+201141141677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026