Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-06 @ 1:00 PM
Study NCT ID:
NCT02543294
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2015-09-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afadol@mdanderson.org', 'phone': '713-792-8397', 'title': 'Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Thirty (30) months from date of enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (Weaning)', 'description': 'Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decrease in Ejection fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', '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).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Weaning)', 'description': '"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"'}], 'classes': [{'title': 'Maintained (LVEF </= 50%)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal Failure (LVEF <50% or decrease of 10%)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Lost to Follow Up', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawal by Subject', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'A total of 30 months from enrollment date of each participant;', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Weaning)', 'description': 'Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'A total of 30 months from enrollment date of each participant', 'description': 'To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (Weaning)', 'description': 'Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (Weaning)', 'description': 'Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Maintenance of LVEF ≥50% after weaning of heart failure medications.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '>/= 30-39', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '>/= 40-49', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '>/= 50-59', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '>/= 60', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Left ventricular ejection fraction (LVEF) ≥50%', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'LVEF ≥50%, taking heart failure medications classified as Angiotension converting enzyme inhibitors (ACE-Inhibitors), Beta-blockers, and/or angiotension-receptor blockers (ARBs), no diabetes, no hypertension, no arrhythmias, cancer in remission for at least 6 months', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients at MD Anderson that met inclusion criteria (specified in Recruitment Details) and not excluded due to: Cancer recurrence; documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis; presence of HF symptoms (e.g. shortness of breath, edema); Pregnancy.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-08-30', 'size': 262718, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-30T15:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2015-09-04', 'resultsFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-27', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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).', 'timeFrame': 'A total of 30 months from enrollment date of each participant;', '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.'}], 'secondaryOutcomes': [{'measure': 'Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.', 'timeFrame': 'A total of 30 months from enrollment date of each participant', 'description': 'To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Heart Failure', 'Cancer Treatment Induced Left Ventricular Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:\n\n* Your complete medical history will be recorded.\n* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).\n* You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.\n* You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.\n* 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.\n* You will be given instructions on how to gradually wean yourself off of your heart failure medication.\n* You will be given a machine that you will use to measure your blood pressure at home.\n\nYou 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.\n\nAt Month 1:\n\n* You will have a physical exam, including measurement of your vital signs.\n* You will complete the questionnaire about any symptoms you may be having.\n* You will have blood (about 2 teaspoons) drawn for routine tests.\n\nAt Months 2, 4, 6, 12, 18, and 30:\n\n* You will have a physical exam, including measurement of your vital signs.\n* You will complete the questionnaire about any symptoms you may be having.\n* You will have an ECHO.\n* You will have blood (about 2 teaspoons) drawn for routine tests.\n\nAt Months 3 and 5, you will have a telephone follow-up with a member of the research team.\n\nLength of Study Participation:\n\nYou 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.\n\nThis is an investigational study.\n\nUp to 45 participants will be enrolled in this study. All will take part at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.\n2. 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).\n3. Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation\n4. Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.\n5. 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.\n6. Residence within the United States.\n7. 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.\n\nExclusion Criteria:\n\n1. Participants will be excluded if they have a recurrence that requires anti-cancer treatment.\n2. Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.\n3. Exhibiting HF symptoms (e.g. shortness of breath, edema).\n4. Pregnancy"}, 'identificationModule': {'nctId': 'NCT02543294', 'briefTitle': 'REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)', 'orgStudyIdInfo': {'id': '2012-0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anthracycline Treatment Group', '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.', 'interventionNames': ['Device: Echocardiograms', 'Device: Electrocardiogram', 'Behavioral: Symptom Questionnaire', 'Behavioral: Telephone Follow-Up']}, {'type': 'EXPERIMENTAL', 'label': 'Herceptin Treatment Group', '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.', 'interventionNames': ['Device: Echocardiograms', 'Device: Electrocardiogram', 'Behavioral: Symptom Questionnaire', 'Behavioral: Telephone Follow-Up']}, {'type': 'EXPERIMENTAL', 'label': 'Combination of Treatments Group', '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.', 'interventionNames': ['Device: Echocardiograms', 'Device: Electrocardiogram', 'Behavioral: Symptom Questionnaire', 'Behavioral: Telephone Follow-Up']}], 'interventions': [{'name': 'Echocardiograms', 'type': 'DEVICE', 'otherNames': ['ECHO'], 'description': 'Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.', 'armGroupLabels': ['Anthracycline Treatment Group', 'Combination of Treatments Group', 'Herceptin Treatment Group']}, {'name': 'Electrocardiogram', 'type': 'DEVICE', 'otherNames': ['ECG'], 'description': 'Electrocardiogram performed at baseline.', 'armGroupLabels': ['Anthracycline Treatment Group', 'Combination of Treatments Group', 'Herceptin Treatment Group']}, {'name': 'Symptom Questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Survey'], 'description': 'Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.', 'armGroupLabels': ['Anthracycline Treatment Group', 'Combination of Treatments Group', 'Herceptin Treatment Group']}, {'name': 'Telephone Follow-Up', 'type': 'BEHAVIORAL', 'description': 'Telephone follow-up by study staff at months 3 and 5.', 'armGroupLabels': ['Anthracycline Treatment Group', 'Combination of Treatments Group', 'Herceptin Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Anecita Fadol, PHD, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}