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CancerPhase 4CardioToxNCT04939883

Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

A Phase 4 study testing Carvedilol in people with Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Neoplasia is the main cause of general death in the Brazilian population. In 2016, they were responsible for approximately 211,343 (16%) deaths, followed by cardiovascular diseases (12.6%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Carvedilol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,018 participants
Where
1 siteBrazil
Study dates
1 Aug 2021to 31 May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age at the time of screening
  • Cancer patients that will receive chemotherapy with anthracyclines.

Who cannot join

  • Inability to adequate asses left ventricular function
  • Previous symptoms (dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, and pulmonary and systemic congestion) suggestive of or a previous diagnosis of heart failure.
  • Previous history of any cardiomyopathy (eg.: valve disease, Chagas' disease, infiltrative cardiomyopathy)
  • LVEF < 50%
  • Previous history of myocardial revascularization
  • Permanent tachyarrhythmia (flutter, atrial fibrillation, atrial tachycardia)
Show all 15Show fewer
  • Congenital heart disease with left ventricular function impared
  • Contra-indication to the use of beta-blockers.
  • Pregnant or Breast-feeding females or women of childbearing age who intend to became pregnant.
  • On kidney replacement therapy
  • ECOG >= 4 or Karnofsky <=30
  • Advanced hepatic failure (C score Child-Pugh and MELD > 15);
  • Previous use of anthracycline
  • Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
  • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Sirio Libanes

    São Paulo, São Paulo, 01308-050

Other trials in Brazil

About this study

Official title: A Prospective Multi-Center Randomized Study to Evaluate the Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

Neoplasia is the main cause of general death in the Brazilian population. In 2016, they were responsible for approximately 211,343 (16%) deaths, followed by cardiovascular diseases (12.6%). Despite the high mortality rate of neoplasia, oncological treatment have advanced substantially in recent decades improving the prognosis of patients. However, growing evidence suggest that some oncological agents may induce significant toxicity that may play a major role in the quality of life, morbidity and mortality. The cardiovascular system is often negatively affected with cancer therapy, predisposing several patients to stop appropriate treatments or to have cardiovascular events related to the cardiotoxicity. The most typical manifestation of cardiotoxicity and related consequences (heart failure) are related to the use of anthracyclines. Anthracyclines are part of the chemotherapy regimen for solid tumors and hematological neoplasms in children and adults, and are associated with an increase in life expectancy. Carvedilol is an α and β-blocker that also has antioxidant properties. Preliminary studies have shown that carvedilol and its metabolites prevent lipid peroxidation, inhibit the formation and inactivate free radicals, in addition to preventing the depletion of endogenous antioxidants, such as vitamin E. These effects would potentially prevent anthracycline injury but definitive evidence is still needed. This is a multi-center, double-blind, randomized, placebo-controlled study that aims to establish the efficacy of carvedilol for the primary prevention of left ventricular systolic dysfunction in cancer patients obtained with anthracycline chemotherapy, in different schedules and doses.

Conditions
Cancer
Being tested
Carvedilol, Placebo
Keywords
Carvedilol, Anthracyclines, Cardiotoxicity, Chemotherapy
Medical subject headings
Neoplasms, Cardiotoxicity

What participants receive

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

  • CarvedilolDrug

    Carvedilol will be dispensed in a staggered and progressive manner, initially from 6.25 mg twice daily, then increased to 12.5 mg twice daily, until maximum dose of 25 mg twice daily or development of contraindications

  • PlaceboDrug

    Patients will receive placebo in a presumed staggered and progressive manner similar to the intervention group. The placebo will ideally be maintained for up to 30 days after the end of chemotherapy.

Study groups in NCT04939883
Study groupRoleWhat they receive
Intervention GroupExperimentalPatients allocated to the intervention group will receive carvedilol 6.25 mg twice daily, then increased to 12.5 mg twice daily, until maximum dose of 25 mg twice daily according to the patients' tolerance; The dosis increments will occur every 5 days. If after the increment the patient develops bradycardia or hypotension, the dose will be reduced to the maximum tolerated dose. Carvedilol will ideally be maintained for up to 30 days after the end of chemotherapy.
Receives: Drug: Carvedilol
Control GroupPlacebo comparatorPatients allocated to this group will receive placebo in a presumably staggered and progressive manner similar to the group intervention. The placebo will ideally be maintained for up to 30 days after the end of chemotherapy.
Receives: Drug: Placebo

What is being measured

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

  1. Drop in ejection fraction within 12 months of starting treatment.

    Drop in ejection fraction> 10% to values less than 50% of the left ventricle

    Measured: 12 months

  2. Cardiac events within 12 months of starting treatment.

    Cardiac events such as death, resuscitated cardiac arrest, myocardial infarction, heart failure and cardiac arrhythmias

    Measured: 12 months

Secondary outcomes (6)

  1. Drop in ejection fraction within 12 months.

    Drop in ejection fraction greater than 10% and values less than 55%

    Measured: 12 months

  2. Reduction in myocardial strain in 12 months from the start of treatment.

    Relative reduction of more than 15% in myocardial strain

    Measured: 12 months

  3. Diastolic dysfunction within 12 months

    Development of diastolic dysfunction within 12 months

    Measured: 12 months

  4. Elevation of biomarkers during chemotherapy and up to 12 months of follow-up

    Elevation of biomarkers (NT-pro BNP and troponin) during chemotherapy and up to 24 months of follow-up

    Measured: 12 months

  5. Quality of life (EuroQol-5D).

    Quality of life measured by questionnaire in up to 12 months.

    Measured: 12 months

  6. Cardiovascular complications in 12 months.

    Cardiovascular complications (death, resuscitated cardiac arrest, myocardial infarction, heart failure and cardiac arrhythmias) in 24 months.

    Measured: 12 months

Timeline

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

  1. First posted25 Jun 2021
  2. Study start1 Aug 2021
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,018 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939883
Sponsor's protocol ID
AVAP-NG 989
Acronym
CardioTox
Status last verified
Aug 2026
First submitted
17 Jun 2021
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costa IBSDS, Furtado RHM, Drager LF, de Barros E Silva PGM, Melo MDT, Araruna P, Bacchiega BC, Cauduro S, Walter E, Fialho GL, Silvestre O, Damiani LP, Barbosa LM, Luz MN, Silva ACA, de Mattos RR, Saretta R, Rehder MHHS, Hajjar LA, Lopes-Fernandez T, Dent S, Gibson CM, Lopes RD, Kalil Filho R; CARDIOTOX Investigators. Effects of carvedilol on the prevention of cardiotoxicity induced by anthracyclines: Design and rationale of the CARDIOTOX trial. Am Heart J. 2025 Jul;285:1-11. doi: 10.1016/j.ahj.2025.02.014. Epub 2025 Feb 22.

    PubMed 39988204

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carvedilol in people with Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.

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 2 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Drop in ejection fraction within 12 months of starting treatment. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04939883, 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 2 Oct 2026.

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