REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
2020年1月27日 更新者：M.D. Anderson Cancer Center
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.
研究概览
地位
完全的
详细说明
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.
At Months 2, 4, 6, 12, 18, and 30:
- 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 an ECHO.
- You will have blood (about 2 teaspoons) drawn for routine tests.
At Months 3 and 5, you will have a telephone follow-up with a member of the research team.
Length of Study Participation:
You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study.
Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Anthracycline Treatment Group
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Electrocardiogram performed at baseline.
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Telephone follow-up by study staff at months 3 and 5.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
其他名称：
Electrocardiogram performed at baseline.
其他名称：
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
其他名称：
Telephone follow-up by study staff at months 3 and 5.
|
|
实验性的：Herceptin Treatment Group
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Electrocardiogram performed at baseline.
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Telephone follow-up by study staff at months 3 and 5.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
其他名称：
Electrocardiogram performed at baseline.
其他名称：
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
其他名称：
Telephone follow-up by study staff at months 3 and 5.
|
|
实验性的：Combination of Treatments Group
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Electrocardiogram performed at baseline.
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Telephone follow-up by study staff at months 3 and 5.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
其他名称：
Electrocardiogram performed at baseline.
其他名称：
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
其他名称：
Telephone follow-up by study staff at months 3 and 5.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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).
大体时间：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.
|
A total of 30 months from enrollment date of each participant;
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
大体时间：A total of 30 months from enrollment date of each participant
|
To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.
|
A total of 30 months from enrollment date of each participant
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anecita Fadol, PHD, MSN、M.D. Anderson Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年9月10日
初级完成 (实际的)
2017年9月10日
研究完成 (实际的)
2017年9月10日
研究注册日期
首次提交
2015年9月4日
首先提交符合 QC 标准的
2015年9月4日
首次发布 (估计)
2015年9月7日
研究记录更新
最后更新发布 (实际的)
2020年2月5日
上次提交的符合 QC 标准的更新
2020年1月27日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.