NCT05792293

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 19, 2023

Last Update Submit

April 4, 2023

Conditions

Doxorubicin Induced Cardiomyopathy

Keywords

AnthracyclinesDoxorubuicnCardiotoxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Study Group

EXPERIMENTAL

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Drug: Atorvastatin 40 Mg Oral Tablet

Control Group

PLACEBO COMPARATOR

Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy

Other: Placebo

Interventions

Atorvastatin 40 Mg Oral TabletDRUG

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

Study Group
PlaceboOTHER

Placebo

Control Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients diagnosed with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Interventions

AtorvastatinTablets

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Ahmed L Mohamed, Master

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed L Mohamed, Master

CONTACT

+201141141677Doc.ahmedlotfy91@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations

EG(1)