Rosuvastatin effect in prevention of anthracycline-induced cardiac dysfunction

Evaluation of Rosuvastatin efficacy in prevention of anthracycline-induced cardiac dysfunction in breast cancer patients after chemotherapy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191002044961N2

Enrollment

400

Registered

2025-10-19

Start date

2025-11-22

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Anthracycline-induced cardiotoxicity in breast cancer patients undergoing chemotherapy. This condition refers to damage to the heart muscle caused by anthracycline-based chemotherapeutic agents, leading to a decline in cardiac function and potential development of heart failure.. Cardiomyopathy due to drug and external agent

Interventions

Intervention group: Consuming 20 milligrams of Rosuvastatin daily for 12 months.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Female individuals with a minimum age of 18 years old Documented breast cancer diagnosis based on imaging and pathology findings Scheduled to receive the first time anthracycline-based chemotherapy

Exclusion criteria

Exclusion criteria: Prior Statin use or Statin use is indicated based on guidelines history of congestive heart failure (CHF) or cardiomyopathy Unexplained persistent elevation of transaminases (>3 times upper limits of normal) Concomitant use of oral cyclosporine Metastatic invasion of cancer to other organs Previous cycles of chemotherapy Any contraindication for statin use Pregnancy or breastfeeding inability or disagreement to provide informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the incidence of CTRCD, defined by a decrease in LVEF of 10% or more, resulting in an LVEF below 55%. Timepoint: 12 months after enrollment. Method of measurement: Echocardiography.	—

Secondary

Measure	Time frame
Changes in LVEF and Global-longitudinal strains (GLS). Timepoint: at 3, 6, and 12 months after enrollment. Method of measurement: Echocardiography.;Changes in Troponin, N-terminal pro b-type Natriuretic Peptide (NT-proBNP), and High-sensitivity C-reactive Protein (hsCRP) serum level. Timepoint: at 3, 6, and 12 months after enrollment. Method of measurement: Laboratory marker, biochemistry kits.;Incidence of DVT, PE, HF, and MACE following anthracycline treatment. Timepoint: 12 months follow-up. Method of measurement: History and Medical document evaluation.	—

Measure

Time frame

Changes in LVEF and Global-longitudinal strains (GLS). Timepoint: at 3, 6, and 12 months after enrollment. Method of measurement: Echocardiography.;Changes in Troponin, N-terminal pro b-type Natriuretic Peptide (NT-proBNP), and High-sensitivity C-reactive Protein (hsCRP) serum level. Timepoint: at 3, 6, and 12 months after enrollment. Method of measurement: Laboratory marker, biochemistry kits.;Incidence of DVT, PE, HF, and MACE following anthracycline treatment. Timepoint: 12 months follow-up. Method of measurement: History and Medical document evaluation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactArmin Attar

Shiraz University of Medical Sciences

attar_armin@yahoo.com+98 84 3347 1964

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026