Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction
Conditions
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
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.
Interventions
DEVICEEchocardiograms
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
DEVICEElectrocardiogram
Electrocardiogram performed at baseline.
BEHAVIORALSymptom Questionnaire
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
BEHAVIORALTelephone Follow-Up
Telephone follow-up by study staff at months 3 and 5.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were identified in the Cardiology outpatient clinic at MD Anderson Cancer Center by research team. Team reviewed cardiac medications (angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin II receptor blocker (ARB), and beta blocker), met with eligible patients, explained study, obtained informed consent, and enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention (Weaning) Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Intervention (Weaning) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 47.9 years STANDARD_DEVIATION 12 |
| Age, Customized < 30 | 1 Participants |
| Age, Customized >/= 30-39 | 6 Participants |
| Age, Customized >/= 40-49 | 3 Participants |
| Age, Customized >/= 50-59 | 6 Participants |
| Age, Customized >/= 60 | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Left ventricular ejection fraction (LVEF) ≥50% | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: A total of 30 months from enrollment date of each participant;
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention (Weaning) | 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). | Maintained (LVEF </= 50%) | 8 Participants |
| Intervention (Weaning) | 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). | Withdrawal Failure (LVEF <50% or decrease of 10%) | 2 Participants |
| Intervention (Weaning) | 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). | Lost to Follow Up | 3 Participants |
| Intervention (Weaning) | 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). | Withdrawal by Subject | 7 Participants |
Secondary
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.
Time frame: A total of 30 months from enrollment date of each participant
Population: The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention (Weaning) | Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications. | 0.03 ng/mL | Standard Deviation 0 |