Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity

This study is currently recruiting participants.
Verified November 2012 by University of Sao Paulo
Sponsor:
Collaborators:
Hospital A.C. Camargo
Instituto do Cancer do Estado de São Paulo
Information provided by (Responsible Party):
Edimar Alcides Bocchi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01724450
First received: June 11, 2012
Last updated: November 6, 2012
Last verified: November 2012

June 11, 2012
November 6, 2012
June 2012
June 2016   (final data collection date for primary outcome measure)
Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01724450 on ClinicalTrials.gov Archive Site
Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity
Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.

The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies.

Initial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.These patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Breast Cancer
  • Heart Failure
  • Cardiotoxicity
  • Drug: Carvedilol
    50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
  • Drug: Placebo
    Placebo similar to the carvedilol up titration but wit no active drug.
  • Active Comparator: Carvedilol
    Intervention: Drug: Carvedilol
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.

Exclusion Criteria:

Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers.

Patients with HER 2 expression

Female
18 Years and older
No
Contact: Edimar Alcides Bocchi, PHD +551126615419 edimar.bocchi@incor.usp.br
Contact: Silvia Moreira Ayub-Ferreira, PHD +551126615419 silvia.ayub@incor.usp.br
Brazil
 
NCT01724450
Cardiotox Incor
No
Edimar Alcides Bocchi, University of Sao Paulo
University of Sao Paulo
  • Hospital A.C. Camargo
  • Instituto do Cancer do Estado de São Paulo
Principal Investigator: Edimar Alcides Bocchi, PHD Heart Institute of University of Sao Paulo
University of Sao Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP