REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Sep 2012
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2015
CompletedFirst Posted
Study publicly available on registry
September 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2017
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 5, 2020
January 1, 2020
5 years
September 4, 2015
May 1, 2018
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
Anthracycline Treatment Group
EXPERIMENTALParticipants 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.
Herceptin Treatment Group
EXPERIMENTALParticipants 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.
Combination of Treatments Group
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Anecita Fadol, PHD, MSN
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2015
First Posted
September 7, 2015
Study Start
September 10, 2012
Primary Completion
September 10, 2017
Study Completion
September 10, 2017
Last Updated
February 5, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-01