AzTrials
AzTrials

Anthracyclines-Induced CardiotoxicityPhase 2DAPA-AICNCT06888505

Dapagliflozin to Prevent Anthracycline-Induced Cardiotoxicity

A Phase 2 study testing Dapagliflozin (Forxiga) in people with Anthracyclines-Induced Cardiotoxicity and Cardiotoxicity, run by Hawler Medical University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Anthracyclines, such as doxorubicin, are effective anticancer agents but may cause dose-dependent cardiac injury, including early changes in left ventricular function and cardiac biomarkers. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Dapagliflozin (Forxiga)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
1 siteIraq
Study dates
1 Sep 2024to 6 Sep 2025
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed breast cancer (or other cancers as relevant to the study).
  • Age 18-70 years.
  • Planned treatment with anthracycline-based chemotherapy
  • Normal kidney function, defined as serum creatinine 0.6-1.2 mg/dL.
  • Normal liver function, defined as ALT and AST 10-40 U/L.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Willingness to participate and provide written informed consent.

Who cannot join

  • History of symptomatic heart failure (NYHA class III-IV) or prior anthracycline-related cardiac dysfunction.
  • Previous use of Dapagliflozin.
  • Pregnancy or breastfeeding.
  • Severe renal impairment (eGFR < 30 mL/min/1.73m²).
  • Uncontrolled diabetes mellitus (HbA1c > 9%).
  • Active or recurrent urinary tract infections (UTIs) within the last 6 months.
  • Known hypersensitivity to Dapagliflozin or related compounds.
  • Concurrent participation in another clinical trial investigating cardioprotective agents.

Trial locations and contacts

1 site in 1 country.

Iraq1 site
  • Azadi Oncology Centre

    Duhok, Duhok Governorate, 42001

Other trials in Iraq

About this study

Official title: Mitigating Anthracycline-Induced Cardiac Toxicity With Dapagliflozin: A Randomized, Double-Blind, Placebo-Controlled Trial of 10 mg Daily for Four Months

Anthracyclines, such as doxorubicin, are effective anticancer agents but may cause dose-dependent cardiac injury, including early changes in left ventricular function and cardiac biomarkers. Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor with established cardiovascular benefits in heart failure and potential cardioprotective effects beyond glucose lowering, including modulation of oxidative stress, inflammation, myocardial energetics and fibrotic remodeling.

This randomized, double-blind, placebo-controlled phase 2 trial evaluated whether dapagliflozin attenuates early anthracycline-associated cardiac functional and biomarker changes in adults receiving anthracycline-based chemotherapy. A total of 94 participants were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once daily plus standard anthracycline-based chemotherapy or matching placebo plus standard anthracycline-based chemotherapy for 4 months. Ninety participants completed the 4-month follow-up and were included in complete-case analyses.

Read more

The primary echocardiographic outcome was change in left ventricular function from baseline to 4 months. Left ventricular systolic function was assessed using left ventricular ejection fraction (LVEF) as the principal systolic measure. Transmitral E/A ratio was analyzed as an exploratory filling index because it was consistently available across participants. Tissue Doppler indices and comprehensive diastolic dysfunction grading were not consistently available and were therefore not used for formal diastolic grading in the final analysis.

Secondary outcomes included cardiac troponin I, NT-proBNP, galectin-3, CA 15-3, renal and hepatic function parameters, and adverse events. Echocardiography and laboratory biomarkers were assessed at baseline and 4 months, while adverse events were monitored continuously throughout the study period.

Read the detailed description

Chemotherapy-induced cardiotoxicity is an important concern in cancer care, particularly among patients receiving anthracycline-based chemotherapy. Anthracycline-associated myocardial injury may involve oxidative stress, mitochondrial dysfunction, inflammation, cardiomyocyte injury and myocardial remodeling. Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiovascular benefits in heart failure and may also influence biological pathways relevant to anthracycline-associated cardiac injury.

This randomized, double-blind, placebo-controlled phase 2 trial was designed to evaluate the potential cardioprotective effects of dapagliflozin in adult cancer patients receiving anthracycline-based chemotherapy.

The study was conducted at Azadi Oncology Center, Duhok, Iraq, affiliated with Hawler Medical University and the Duhok General Health Directorate. The center is now known as Omed Oncology Hospital. All participants were recruited at this single site.

A total of 94 participants were randomized in a 1:1 ratio. Forty-seven participants were allocated to dapagliflozin 10 mg orally once daily plus standard anthracycline-based chemotherapy, and 47 participants were allocated to matching placebo plus standard anthracycline-based chemotherapy. Study treatment was continued for 4 months. Four participants withdrew consent during follow-up, leaving 45 participants in each group with complete baseline and 4-month follow-up data for complete-case analyses.

The primary echocardiographic outcome was change in left ventricular function from baseline to 4 months. Left ventricular systolic function was assessed using change in LVEF as the principal systolic measure. The diastolic component was assessed using transmitral E/A ratio, which was consistently available across participants and was analyzed as an exploratory filling index. Tissue Doppler indices and comprehensive ASE/EACVI-based diastolic dysfunction grading were not consistently available and were therefore not used for formal diastolic grading in the final analysis.

Secondary outcomes included changes in cardiac troponin I, NT-proBNP, galectin-3, CA 15-3, renal function parameters, hepatic function parameters and adverse events. Echocardiography and laboratory biomarkers were assessed at baseline and 4 months. Adverse events were monitored throughout the 4-month treatment and follow-up period and graded according to CTCAE criteria where applicable.

Comparative analyses were performed using change-from-baseline values. Between-group differences in continuous outcomes were assessed using independent-samples t-tests or Mann-Whitney U tests according to data distribution. Categorical variables were compared using chi-square or Fisher's exact tests where appropriate. The primary analysis was performed as a complete-case analysis among participants with available baseline and 4-month follow-up data. No imputation was used for the primary analysis.

The study was approved by the Hawler Medical University Ethics Committee and the Duhok General Health Directorate. Written informed consent was obtained from all participants before enrollment.

Being tested
Dapagliflozin (Forxiga), Placebo
Keywords
cardiotoxicity, Anthracycline-induced cardiotoxicity, Dapagliflozin, SGLT2 inhibitors, cardio-oncology, Cardiac biomarkers in chemotherapy, Heart failure in cancer patients
Medical subject headings
Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin (Forxiga)Drug

    Also called Farxiga

    Participants in the dapagliflozin arm received dapagliflozin 10 mg tablets, administered orally once daily for 4 months, in addition to their standard anthracycline-based chemotherapy regimen. This treatment was given continuously throughout the chemotherapy period to evaluate its cardioprotective effects against anthracycline-induced cardiac toxicity.

  • PlaceboOther

    Also called Inactive tablet

    Participants in the control arm received a placebo tablet identical in appearance, dosage form, frequency, and duration to dapagliflozin, but containing no active ingredients. The placebo was administered orally once daily for 4 months alongside the participant's standard anthracycline-based chemotherapy regimen and served as the control to evaluate the cardioprotective efficacy of dapagliflozin.

Study groups in NCT06888505
Study groupRoleWhat they receive
Dapagliflozin ArmActive comparatorParticipants in this arm received dapagliflozin 10 mg orally once daily in addition to their standard anthracycline-based chemotherapy regimen. Dapagliflozin was continued daily for four months (throughout the chemotherapy treatment period). The study evaluated its potential cardioprotective effects against anthracycline-induced cardiac toxicity using echocardiography, cardiac biomarkers, and safety monitoring.
Receives: Drug: Dapagliflozin (Forxiga)
Control ArmPlacebo comparatorParticipants in this arm received a placebo tablet identical in appearance, dosage form, frequency, and duration to dapagliflozin. The placebo was administered orally once daily for four months, alongside the participant's standard anthracycline-based chemotherapy regimen. The placebo contained no active ingredients and served as the control to evaluate the cardioprotective efficacy of dapagliflozin.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular function assessed by echocardiography.

    Change in left ventricular function from baseline to 4 months was assessed using left ventricular ejection fraction (LVEF) as the principal systolic measure and transmitral E/A ratio as an exploratory filling index. Tissue Doppler indices and comprehensive diastolic dysfunction grading were not consistently available and were therefore not used for formal diastolic grading in the final analysis.

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

Secondary outcomes (7)
  1. Cardiac Troponin I Levels

    Measurement of serum Troponin I levels to assess myocardial injury and cardiac stress in patients undergoing chemotherapy.

    Measurement Tool: Chemiluminescent Immunoassay (CLIA).

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  2. NT-proBNP Levels

    Measurement of serum NT-proBNP levels as an indicator of cardiac stress and dysfunction.

    Measurement Tool: Chemiluminescent Immunoassay (CLIA).

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  3. Galectin-3 Levels

    Measurement of serum Galectin-3 levels to evaluate its role in oxidative stress, apoptosis, and tissue remodeling.

    Measurement Tool: Enzyme-Linked Immunosorbent Assay (ELISA).

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  4. CA 15-3 Levels

    Measurement of serum CA 15-3 levels to monitor breast cancer cell proliferation.

    Measurement Tool: Chemiluminescent immunoassay

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  5. Kidney Function Tests

    Monitoring of serum creatinine and blood urea nitrogen (BUN) to assess renal function and potential nephrotoxicity related to chemotherapy or Dapagliflozin.

    Measurement Tool: Automated Biochemical Analyzer for serum creatinine and BUN.

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  6. Complete Blood Count (CBC)

    Monitoring of hematological parameters (e.g., hemoglobin, white blood cells, platelets) to assess overall health, immune function, and tolerability of treatment.

    Measurement Tool: Automated Hematology Analyzer (Beckman Coulter analyzers).

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

  7. Liver Function Tests (LFTs)

    Monitoring of liver enzymes (e.g., ALT, AST, alkaline phosphatase, bilirubin) to assess liver function and potential hepatotoxicity due to chemotherapy or Dapagliflozin.

    Measurement Tool: Chemiluminescent Immunoassay

    Measured: Evaluated at baseline and 4 months after initiation of chemotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start1 Sep 2024
  3. Primary completion1 Sep 2025
  4. Study completion6 Sep 2025

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized, double-blind, placebo-controlled trial investigating the efficacy of Dapagliflozin in preventing chemotherapy-induced cardiotoxicity in cancer patients receiving anthracycline-based chemotherapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888505
Sponsor's protocol ID
HSaeed
Other IDs
Hawler Medical University, Duhok Directorate of Health
Acronym
DAPA-AIC
Status last verified
Jun 2026
First submitted
3 Mar 2025
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At this time, individual participant data (IPD) will not be shared publicly. The data will be kept confidential to ensure participant privacy and comply with ethical and regulatory requirements, including those related to informed consent and data protection. Access to the data may be considered for future collaborations under strict ethical guidelines and approval from the relevant oversight bodies.

Publications

  • Saeed HA, Mohammed Ali NA, Othman RT. Dapagliflozin for attenuating early anthracycline-associated cardiac changes (DAPA-AIC): a randomized, double-blind, placebo-controlled trial. Future Sci OA. 2026 Dec;12(1):2741250. doi: 10.1080/20565623.2026.2741250. Epub 2026 Oct 6.

    PubMed 42836855

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin (Forxiga) in people with Anthracyclines-Induced Cardiotoxicity and Cardiotoxicity, run by Hawler Medical University at 1 site in Iraq.

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 7 inclusion and 8 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: finished, as of the sponsor's last update on 16 Jun 2026. 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 Iraq. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular function assessed by echocardiography. (time frame: Evaluated at baseline and 4 months after initiation of chemotherapy.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06888505, which also lists 1 linked publication.

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 16 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in