REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)



Status:Active, not recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2012

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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.

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.

Inclusion Criteria:

1. Cancer survivors with no evidence of disease for at least 6 months as determined by
the oncologist and no longer receiving cancer treatment.

2. 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).

3. Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis,
or hemochromatosis) per chart review of the clinician's documentation

4. Documented normal LVEF for at least 6 months after the initiation of recommended HF
therapy.

5. 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.

6. Residence within the United States.

7. 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:

1. Participants will be excluded if they have a recurrence that requires anti-cancer
treatment.

2. Have a documented history of hypertension, coronary artery disease, myocardial
infarction, diabetes mellitus, amyloidosis or hemochromatosis.

3. Exhibiting HF symptoms (e.g. shortness of breath, edema).

4. Pregnancy
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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