Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

NCT ID: NCT06684509

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2029-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Leukemia Hodgkin Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Non Atrovastatin group

control group of the same condition they will not tkae atrovastatin

Group Type NO_INTERVENTION

No interventions assigned to this group

Atrovastatin group

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

Group Type EXPERIMENTAL

Atrovastain

Intervention Type DRUG

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

Interventions

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Atrovastain

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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%

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Mahmoud Abd Rabou

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Esraa AbdRabou, Bacheolar of medicine

Role: CONTACT

+201151477447

Facility Contacts

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Assiut university

Role: primary

088-2354130

Other Identifiers

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Atorvaststin and cardiotoxicit

Identifier Type: -

Identifier Source: org_study_id

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