Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Heart Failure
Cardiotoxicity
Drug: Carvedilol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carvedilol Drug: Carvedilol
50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
Placebo Comparator: Control Drug: Placebo
Placebo similar to the carvedilol up titration but wit no active drug.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724450

Contacts
Contact: Edimar Alcides Bocchi, PHD +551126615419 edimar.bocchi@incor.usp.br
Contact: Silvia Moreira Ayub-Ferreira, PHD +551126615419 silvia.ayub@incor.usp.br

Locations
Brazil
Heart Institute University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Edimar Alcides Bocchi, PHD    +551126615419    edimar.bocchi@incor.usp.br   
Contact: Silvia Moreira Ayub-Ferreira, PHD    +551126615419    silvia.ayub@incor.usp.br   
Sub-Investigator: Monica Samuel Avila, MD         
Sub-Investigator: Solange Moraes Sanches, MD         
Sponsors and Collaborators
University of Sao Paulo
Hospital A.C. Camargo
Instituto do Cancer do Estado de São Paulo
Investigators
Principal Investigator: Edimar Alcides Bocchi, PHD Heart Institute of University of Sao Paulo
  More Information

No publications provided

Responsible Party: Edimar Alcides Bocchi, phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01724450     History of Changes
Other Study ID Numbers: Cardiotox Incor
Study First Received: June 11, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Breast Cancer
Heart Failure
Cardiotoxicity
Biomarkers

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Heart Failure
Heart Diseases
Cardiovascular Diseases
Skin Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on September 18, 2014