Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

NCT06684509 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: Atorvaststin and cardiotoxicit
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL). The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy. The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin. The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.

Conditions

Leukemia; Hodgkin Disease

Keywords

Cardiotoxicity; Atrovastatin

Outcome Measures

Primary Outcomes (1)

• Cardiotoxicity

  Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG

  During the study period along 12 months

Secondary Outcomes (1)

• Cardiotoxicity events correlation to high risk patients

  along 12 months

Study Arms (2)

Non Atrovastatin group

NO INTERVENTION

control group of the same condition they will not tkae atrovastatin

Atrovastatin group

EXPERIMENTAL

patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Drug: Atrovastain

Interventions

Atrovastain DRUG

atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

Atrovastatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%

You may not qualify if:

• Cardiac dysfunction with EF \< 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Leukemia; Hodgkin Disease; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Esraa AbdRabou, Bacheolar of medicine

CONTACT

+201151477447; mahmoudisraa01@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)