Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity
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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. |
- 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 ]
- 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 |
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| Contact: Edimar Alcides Bocchi, PHD | +551126615419 | edimar.bocchi@incor.usp.br |
| Contact: Silvia Moreira Ayub-Ferreira, PHD | +551126615419 | silvia.ayub@incor.usp.br |
| 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 | |
| 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 Heart Failure Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Heart Diseases Cardiovascular Diseases Adrenergic beta-Antagonists Carvedilol 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 June 17, 2013