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Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity (Ceccy)

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ClinicalTrials.gov Identifier: NCT01724450
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : February 2, 2018
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

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

Condition or disease Intervention/treatment Phase
Breast Cancer Heart Failure Cardiotoxicity Drug: Carvedilol Drug: Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724450


Locations
Brazil
Heart Institute University of Sao Paulo
Sao Paulo, Brazil, 05403-000
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edimar Alcides Bocchi, phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01724450     History of Changes
Other Study ID Numbers: Ceccy Trial
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by Edimar Alcides Bocchi, University of Sao Paulo:
Breast Cancer
Heart Failure
Cardiotoxicity
Biomarkers

Additional relevant MeSH terms:
Heart Failure
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists