AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Delta change in left ventricular ejection fraction [LVEF])
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To compare cardiac function changes (delta left ventricular ejection fraction [LVEF]) over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
SECONDARY OBJECTIVE:
I. To compare cardiac function recovery rates over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
II. To compare the time to recovery of cardiac function in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age.
- •New diagnosis of reduced cardiac function.
- •Any prior anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma.
排除标准
- •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.
研究组 & 干预措施
Group I (carvedilol, lisinopril)
Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
干预措施: Carvedilol (Drug)
Group I (carvedilol, lisinopril)
Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
干预措施: Lisinopril (Drug)
Group II (pravastatin, spironolactone)
Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
干预措施: Carvedilol (Drug)
Group II (pravastatin, spironolactone)
Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
干预措施: Lisinopril (Drug)
Group II (pravastatin, spironolactone)
Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
干预措施: Pravastatin (Drug)
Group II (pravastatin, spironolactone)
Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
干预措施: Spironolactone (Drug)
结局指标
主要结局
Delta change in left ventricular ejection fraction [LVEF])
时间窗: Baseline up to 6 months
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.
次要结局
- Time to recovery of cardiac function between group 1 and group 2(Baseline up to 6 months)
- Cardiac function recovery rates between group 1 and group 2(Baseline up to 6 months)