Doxorubicin Induced CardiomyopathyPhase 2/3NCT05792293
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
A Phase 2/3 study testing Atorvastatin 40 Mg Oral Tablet in people with Doxorubicin Induced Cardiomyopathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Doxorubicin Induced Cardiomyopathy
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospitals
Cairo
Ahmed L Mohamed, Master, +201141141677, Doc.ahmedlotfy91@gmail.com
About this study
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity
Read the 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.
- Conditions
- Doxorubicin Induced Cardiomyopathy
- Being tested
- Atorvastatin 40 Mg Oral Tablet, Placebo
- Keywords
- Anthracyclines, Doxorubuicn, Cardiotoxicity
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy Receives: Drug: Atorvastatin 40 Mg Oral Tablet |
| Control Group | Placebo comparator | Fifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Secondary outcomes (3)
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups
Measured: Six months
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
Measured: Six months
Changes in left ventricular diastolic function among the two groups
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doxorubicin Induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Lotfy Mohamed, Ain Shams University
- Investigators
- Ahmed L Mohamed, Master, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792293
- Sponsor's protocol ID
- FMASUMD45/2021
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
- ClinicalTrials.gov ID
- NCT05792293
- Acronym / sponsor ID
- FMASUMD45/2021
- Conditions
- Doxorubicin Induced Cardiomyopathy
- Keywords
- Anthracyclines, Doxorubuicn, Cardiotoxicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Atorvastatin 40 Mg Oral TabletFifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy |
| Control Group | Placebo comparator | Other: PlaceboFifty female patients diagnosed with breast cancer receiving Anthracycline based chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 40 Mg Oral Tablet40 mg oral dose of atorvastatin , lipid lowering drug with other pleotropic effects | Drug | Study Group |
| PlaceboPlacebo | Other | Control Group |
Primary outcome
Incidence of cancer therapy related cardiac dysfunction among the two groups
Time frame: 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
3 secondary outcomes
Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups
Time frame: Six months
Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
Time frame: Six months
Changes in left ventricular diastolic function among the two groups
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Doxorubicin Induced Cardiomyopathy
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The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
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RecruitingPhase 2
Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiomyopathy, Breast Cancer
Not yet recruitingPhase 1/2
Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients
Breast Cancer, Doxorubicin Induced Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed L Mohamed, Master principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atorvastatin 40 Mg Oral Tablet in people with Doxorubicin Induced Cardiomyopathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed L Mohamed, Master (+201141141677, Doc.ahmedlotfy91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cancer therapy related cardiac dysfunction among the two groups (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.