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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cancer Treatment Induced Left Ventricular Dysfunction
• Intervention / Treatment: Device: Echocardiograms; Device: Electrocardiogram; Behavioral: Symptom Questionnaire; Behavioral: Telephone Follow-Up

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Echocardiograms; Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.; Other Names: ECHO; Device: Electrocardiogram; Electrocardiogram performed at baseline.; Other Names: ECG; Behavioral: Symptom Questionnaire; Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.; Other Names: Survey; Behavioral: Telephone Follow-Up; Telephone follow-up by study staff at months 3 and 5.
Experimental: 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.	Device: Echocardiograms; Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.; Other Names: ECHO; Device: Electrocardiogram; Electrocardiogram performed at baseline.; Other Names: ECG; Behavioral: Symptom Questionnaire; Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.; Other Names: Survey; Behavioral: Telephone Follow-Up; Telephone follow-up by study staff at months 3 and 5.
Experimental: 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.	Device: Echocardiograms; Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.; Other Names: ECHO; Device: Electrocardiogram; Electrocardiogram performed at baseline.; Other Names: ECG; Behavioral: Symptom Questionnaire; Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.; Other Names: Survey; Behavioral: Telephone Follow-Up; Telephone follow-up by study staff at months 3 and 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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;

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Anecita Fadol, PHD, MSN, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2012
• Primary Completion (Actual): September 10, 2017
• Study Completion (Actual): September 10, 2017

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Questionnaire; Survey; Electrocardiogram; HF; Echocardiogram; ECG; Left ventricular ejection fraction; LVEF; ECHO; Telephone Follow-Up; Cancer treatment induced left ventricular dysfunction; CILVD
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: 2012-0379