Lymphoma Clinical Trial
Official title:
AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial
Verified date | May 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial compares two drug therapy plans for the correction of heart function changes (reduced ejection function) in patients who have undergone anthracycline-based treatment for lymphoma, sarcoma, or breast cancer. "Reduced ejection fraction" means the left ventricle of the heart is pumping a reduced blood volume with each heartbeat. Treatment is recommended, and the purpose of this research is to compare two different drug therapy plans (standard therapy with carvedilol and lisinopril and standard therapy with carvedilol and lisinopril plus pravastatin and spironolactone) and their effects on improvement of heart function. All of these drugs are heart medications, and carvedilol and lisinopril are commonly used to improve heart function. Adding pravastatin, a cholesterol lowering drug with additional beneficial effects on the cardiovascular system, and spironolactone, a water pill with additional beneficial effects on the cardiovascular system, may lead to even better (and faster) improvements in heart function.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 18, 2023 |
Est. primary completion date | April 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >= 18 years of age. - New diagnosis of reduced cardiac function. - Any prior anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma. Exclusion Criteria: - History of heart failure (HF) of any class and type, or diagnosis of cardiomyopathy prior to anthracycline therapy. - On active therapy with a fibrate, niacin or eplerenone, or statin. - History of myopathy/rhabdomyolysis. - History of statin intolerance. - Active treatment for hyperlipidemia. - History of gout. - Active treatment for liver disease. - Unexplained persistent elevations of serum transaminases (above upper limit of normal over two weeks). - Pregnancy. - Breast-feeding. - Hyperkalemia (above upper limit of normal). - Addison disease. - Estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Mayo Clinic | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta change in left ventricular ejection fraction [LVEF]) | Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions. | Baseline up to 6 months | |
Secondary | Cardiac function recovery rates between group 1 and group 2 | Incidence rates will be compared using a simple test for equality of binomial proportions (? ^ 2 -test or Fisher Exact). | Baseline up to 6 months | |
Secondary | Time to recovery of cardiac function between group 1 and group 2 | Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions. | Baseline up to 6 months |
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