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Trial Outcomes & Findings for REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial) (NCT NCT02543294)

NCT ID: NCT02543294

Last Updated: 2020-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

A total of 30 months from enrollment date of each participant;

Results posted on

2020-02-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Intervention (Weaning)
Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
Overall Study
STARTED
20
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
12

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention (Weaning)
Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
Overall Study
Lost to Follow-up
3
Overall Study
Physician Decision
2
Overall Study
Withdrawal by Subject
7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention (Weaning)
n=20 Participants
Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
47.9 years
STANDARD_DEVIATION 12 • n=5 Participants
Age, Customized
< 30
1 Participants
n=5 Participants
Age, Customized
>/= 30-39
6 Participants
n=5 Participants
Age, Customized
>/= 40-49
3 Participants
n=5 Participants
Age, Customized
>/= 50-59
6 Participants
n=5 Participants
Age, Customized
>/= 60
4 Participants
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=5 Participants
Region of Enrollment
United States
20 Participants
n=5 Participants
Left ventricular ejection fraction (LVEF) ≥50%
20 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Intervention (Weaning)
n=20 Participants
"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"
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
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
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
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 outcome

Timeframe: 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

To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.

Outcome measures

Outcome measures
Measure
Intervention (Weaning)
n=20 Participants
"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"
Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
0.03 ng/mL
Standard Deviation 0

Adverse Events

Intervention (Weaning)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Intervention (Weaning)
n=20 participants at risk
Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)
Cardiac disorders
Decrease in Ejection fraction
10.0%
2/20 • Number of events 2 • Thirty (30) months from date of enrollment

Additional Information

Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing

UT MD Anderson Cancer Center

Phone: 713-792-8397

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place