Carvedilol for Cardiomyopathies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA
Cardiomyopathies+6 More
Carvedilol - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help reduce the risk of heart problems in women with breast cancer.

See full description

Eligible Conditions

  • Cardiomyopathies
  • Breast Cancer
  • Toxicity Due to Chemotherapy
  • Heart Failure
  • Cardiotoxicity
  • Cardiovascular Risk

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Carvedilol will improve 3 primary outcomes and 6 secondary outcomes in patients with Cardiomyopathies. Measurement will happen over the course of 12 months.

12 months
Treatment adherence as measured by pill count
Up to 24 months
Adverse Events
up to 24 months
Cardiac Strain measurements by echocardiogram
Diastolic function (E/e') by echocardiogram
Frequency of individuals with clinical heart failure
High-sensitivity Troponin (hsTnT) level
Left Ventricular Ejection Fraction (LVEF)
N-terminal pro B-type natriuetic peptide (NTproBNP) level
Ventricular-arterial coupling measured by echocardiogram

Trial Safety

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Carvedilol
1 of 2
Active Control
Experimental Treatment

This trial requires 69 total participants across 2 different treatment groups

This trial involves 2 different treatments. Carvedilol is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Carvedilol
Drug
Carvedilol will be initiated at 3.125mg twice daily and uptitrated as tolerated in a stepwise fashion to a maximum dose of 25mg twice daily or to a systolic blood pressure (SBP) of 110-120mmHg or heart rate (HR) of 50-55 beats per minute (bpm). Patients will start carvedilol in the evening after first dose of chemotherapy and will continue on medication for 12 months. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.
Usual CareClinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 months for reporting.

Closest Location

Abramson Cancer Center of the University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females
At least 18 years old
Diagnosed with Stage I-III breast cancer with treatment plan to include therapy with anthracyclines and/or trastuzumab in the adjuvant or neo-adjuvant setting
Study team is able to obtain all necessary information for calculating Cardiotoxicity Risk Score (including echocardiographic measurement of left ventricular ejection fraction)

Patient Q&A Section

What are common treatments for cardiotoxicity?

"Cardiotoxicity in the context of chemotherapy is not uncommon as an adverse effect and is usually reversible. Some chemotherapies may be cardiotoxic and should be carefully considered when used for the treatment of breast cancer." - Anonymous Online Contributor

Unverified Answer

What is cardiotoxicity?

"Cardiotoxicity includes the toxicity of agents, drugs and other substances in the body that cause damage to cardiac system. Findings from a recent study, cardiac damage from citalopram overdose may manifest as sudden cardiac death. Cardiotoxicity may occur after the usage of the drug for a long time. Furthermore, even in those who have heart disease, there are no precautions to take." - Anonymous Online Contributor

Unverified Answer

What are the signs of cardiotoxicity?

"Some signs of cardiotoxicity are coughing blood, decreased exercise tolerance, unexplained weight loss and decreased appetite. Other signs are shortness of breath, heart murmur and arrhythmias.\n" - Anonymous Online Contributor

Unverified Answer

What causes cardiotoxicity?

"Results from a recent paper, only 1 out of 9 patients with suspected cardiotoxicity had a congenital heart defect. Therefore, other factors cause cardiotoxicity in this population." - Anonymous Online Contributor

Unverified Answer

How many people get cardiotoxicity a year in the United States?

"In the United States in 1999, 2.5 million people reported cardiotoxicity in the last year, with 10% of mortality attributable to cardiotoxicity. This warrants a serious need for educational campaigns highlighting the impact of cardiotoxicity." - Anonymous Online Contributor

Unverified Answer

Can cardiotoxicity be cured?

"Treatment of acute myeloid leukemia with TPA resulted in a significant increase in QTc and increased risk of premature ventricular complexes (PVC) or fibrillation, which may, in turn, lead to life-threatening cardiac arrest and/or death. Results from a recent paper of this study do not support the use of TPA based on the currently available data." - Anonymous Online Contributor

Unverified Answer

Is carvedilol typically used in combination with any other treatments?

"Carvedilol is associated with only 0.3% of the side effects in patients in the short term. The use of carvedilol did not result in any drug-drug interaction. Long-term data on this issue are yet to be published. However, it can be safely assumed that carvedilol is often used in combination with other drugs." - Anonymous Online Contributor

Unverified Answer

Does cardiotoxicity run in families?

"Because cardiac toxicity is thought to be a heritable trait, identification of family members who are at a higher risk for development of cardiac toxicity will allow early detection and intervention to prevent cardiotoxicity." - Anonymous Online Contributor

Unverified Answer

How serious can cardiotoxicity be?

"The cardiac side effects (e.g. cardiovascular, peripheral artery disease) of the chemotherapeutics used for cancer treatment seem to be similar with or without the presence of an IHD. The use of a chemotherapeutic drug in IHD should be cautiously considered if heart performance is suspected to be impaired due to IHD." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in carvedilol for therapeutic use?

"In a recent study, findings will help define the role of carvedilol in the therapeutic guidelines in order to optimize its use in terms of dosage and duration of treatment. Moreover, they may also be helpful for the medical community to better understand its safety profile and its interactions with other drugs, thus helping to guide better decisions about its management." - Anonymous Online Contributor

Unverified Answer

Has carvedilol proven to be more effective than a placebo?

"In patients with left-ventricular dysfunction, carvedilol is more effective for treating diastolic dysfunction and improving LV systolic function when compared with placebo. Carvedilol's improvement in LV systolic function can be accomplished without worsening systolic function in patients with diastolic dysfunction." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cardiotoxicity?

"[Preliminary clinical trials of ACE inhibitors, angiotensin II receptor antagonists and beta-blockers]were conducted, but the research has yet to reach a large-scale randomized controlled trial.\n[However, in a 2008 preliminary clinical trial of the angiotensin II receptor antagonist, losartan, patients treated with losartan had a 3-year survival rate of 64.6!%, considerably greater than that of 33." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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