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

Primary Purpose

Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Echocardiograms
Electrocardiogram
Symptom Questionnaire
Telephone Follow-Up
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Echocardiogram, ECHO, Electrocardiogram, ECG, Questionnaire, Survey, Telephone Follow-Up, HF, Cancer treatment induced left ventricular dysfunction, CILVD, Left ventricular ejection fraction, LVEF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Anthracycline Treatment Group

Herceptin Treatment Group

Combination of Treatments Group

Arm Description

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. 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. 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 4, 2015
Last Updated
January 27, 2020
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02543294
Brief Title
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
Official Title
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2012 (Actual)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
September 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction
Keywords
Heart Failure, Echocardiogram, ECHO, Electrocardiogram, ECG, Questionnaire, Survey, Telephone Follow-Up, HF, Cancer treatment induced left ventricular dysfunction, CILVD, Left ventricular ejection fraction, LVEF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anthracycline Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Herceptin Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Combination of Treatments Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Echocardiograms
Other Intervention Name(s)
ECHO
Intervention Description
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Intervention Type
Device
Intervention Name(s)
Electrocardiogram
Other Intervention Name(s)
ECG
Intervention Description
Electrocardiogram performed at baseline.
Intervention Type
Behavioral
Intervention Name(s)
Symptom Questionnaire
Other Intervention Name(s)
Survey
Intervention Description
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Follow-Up
Intervention Description
Telephone follow-up by study staff at months 3 and 5.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
A total of 30 months from enrollment date of each participant;
Secondary Outcome Measure Information:
Title
Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
Description
To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.
Time Frame
A total of 30 months from enrollment date of each participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anecita Fadol, PHD, MSN
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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

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