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Carvedilol in Metastatic HER-2+ Breast Cancer for Prevention of Cardiac Toxicity (PSCI# 20-135) (S1501)
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.
Patients must be ≥ 18 years of age.
Patients must have a complete physical examination and medical history within 28 days prior to registration.
Patients must not be dialysis dependent
Patients must be able to swallow tablets.
Patients have uncontrolled asthma.
Patients who are pregnant or nursing
Patients who are unable to swallow tablets.
Patients who do not have adequate hepatic function
HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
To see how ziltivekimab taken once monthly versus placebo, both added to standard of care, in reducing the risk of cardiovascular death and heart failure events in participants with heart failure iwht mildly reduced or preserved ejection fraction and systemic inflammation.
Return for on site visits 14 times, participate in 6 phone calls, complete questionnaires, blood samples taken at each on-site visit, electrocardiogram completed on 5 visits, injection of study medication.
approximatley $1,120
age 18 years or above
unstable medical therapy for heart failure
active hepatitis C
pregnant females or females not using effective contraceptive
A Phase III, Randomised, Double-blind Study to Evaluate theEffect of Balcinrenone/Dapagliflozin, Compared withDapagliflozin, on the Risk of Heart Failure Events andCardiovascular Death in Patients with Heart Failure and ImpairedKidney Function (BalanceD-HF, D6402C00012))
The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization
Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.
up to $1,600
being treated for heart failure
undergoing treatment for decreased kidney function
major heart surgery within the past 3 months
complicated heart defects at birth or severe uncorrected valve disease