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

Not Applicable

Completed

Conditions: Heart Failure
Cancer Treatment Induced Left Ventricular Dysfunction

Interventions: Device: Echocardiograms
Device: Electrocardiogram
Behavioral: Symptom Questionnaire
Behavioral: Telephone Follow-Up

Registration Number: NCT02543294

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anthracycline Treatment Group	Electrocardiogram	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.
Anthracycline Treatment Group	Echocardiograms	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.
Anthracycline Treatment Group	Symptom Questionnaire	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.
Combination of Treatments Group	Echocardiograms	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.
Combination of Treatments Group	Symptom Questionnaire	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.
Combination of Treatments Group	Telephone Follow-Up	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.
Anthracycline Treatment Group	Telephone Follow-Up	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.
Combination of Treatments Group	Electrocardiogram	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.
Herceptin Treatment Group	Echocardiograms	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.
Herceptin Treatment Group	Electrocardiogram	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.
Herceptin Treatment Group	Symptom Questionnaire	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.
Herceptin Treatment Group	Telephone Follow-Up	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.

Primary Outcome Measures

Name	Time	Method
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).	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.

Secondary Outcome Measures

Name	Time	Method
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	To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.