REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).
研究概览
简要总结
The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.
详细描述
If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
- You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
- You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
- You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
- You will be given instructions on how to gradually wean yourself off of your heart failure medication.
- You will be given a machine that you will use to measure your blood pressure at home.
You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.
At Month 1:
- You will have a physical exam, including measurement of your vital signs.
- You will complete the questionnaire about any symptoms you may be having.
- You will have blood (about 2 teaspoons) drawn for routine tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.
- •Prior diagnosis of CILVD with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker).
- •Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation
- •Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.
- •Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age.
- •Residence within the United States.
- •Ability to read and write English, because the MD Anderson Symptom Inventory -Heart Failure (MDASI-HF) instrument (Fadol et al., 2008) has been validated in English only.
排除标准
- •Participants will be excluded if they have a recurrence that requires anti-cancer treatment.
- •Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.
- •Exhibiting HF symptoms (e.g. shortness of breath, edema).
结局指标
主要结局
Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).
时间窗: A total of 30 months from enrollment date of each participant;
A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF\<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.
次要结局
- Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.(A total of 30 months from enrollment date of each participant)