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

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cancer Treatment Induced Left Ventricular Dysfunction
• Heart Failure
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

• NCT number: NCT02543294
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: N/A
• Start date: September 10, 2012
• Completion date: September 10, 2017