N/A
N=20
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
Heart Failure · Cancer Treatment Induced Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02543294 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: 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). — 8; 2; 3; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Echocardiograms (Device); Electrocardiogram (Device); Symptom Questionnaire (Behavioral); Telephone Follow-Up (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
8; 2; 3; 7 | — |
| SECONDARY Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications. |
0.03 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02543294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.