Trial Outcomes & Findings for The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC) (NCT NCT01705509)
NCT ID: NCT01705509
Last Updated: 2020-02-18
Results Overview
CPET parameters assessed will include the peak VO2: measures the peak transport of O2 to the tissues when O2 extraction from the blood is maximal; 2) the anaerobic threshold (AT): measures the sustainable work capacity in units of VO2; 3) the O2-pulse measurements at the AT and peak VO2: estimate stroke volume at those levels of exercise; and 4) the relationship of O2 uptake to work rate (ΔVO2/ΔWR): provides information on the ability of the cardiac output to increase.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
30 days
Results posted on
2020-02-18
Participant Flow
Participant milestones
| Measure |
CPET Control / CPET With Ranexa
The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison.
|
|---|---|
|
Inclusion CPET
STARTED
|
14
|
|
Inclusion CPET
COMPLETED
|
7
|
|
Inclusion CPET
NOT COMPLETED
|
7
|
|
CPET w/ Ranexa
STARTED
|
7
|
|
CPET w/ Ranexa
COMPLETED
|
5
|
|
CPET w/ Ranexa
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CPET Control / CPET With Ranexa
The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison.
|
|---|---|
|
Inclusion CPET
Screen Failure
|
5
|
|
Inclusion CPET
Withdrawal by Subject
|
2
|
|
CPET w/ Ranexa
Screen Failure
|
2
|
Baseline Characteristics
The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC)
Baseline characteristics by cohort
| Measure |
CPET Control / CPET With Ranexa
n=14 Participants
Enrolled patients will undergo a CPET evaluation. Beta Blockers will be held day prior to and day of CPET. The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg B ID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison. The initial off treatment CPET measurement will serve as the control to assess changes found during therapy. No medication changes or revascularization procedures will occur during the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Number of Participants who Reached CPET Milestones
CPET parameters assessed will include the peak VO2: measures the peak transport of O2 to the tissues when O2 extraction from the blood is maximal; 2) the anaerobic threshold (AT): measures the sustainable work capacity in units of VO2; 3) the O2-pulse measurements at the AT and peak VO2: estimate stroke volume at those levels of exercise; and 4) the relationship of O2 uptake to work rate (ΔVO2/ΔWR): provides information on the ability of the cardiac output to increase.
Outcome measures
| Measure |
Control
n=14 Participants
All patients who meet the criteria of ischemia will receive ranolazine after enrollment. The initial CPET will serve as the control. The second CPET after 30-days of therapy will serve as the therapy arm. CPET parameters will be assessed and compared both on and off therapy.
Ranolazine: The intervention will be ranolazine therapy after the initial CPET. The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison. The initial off treatment CPET measurement will serve as the control to assess changes found during therapy.
|
|---|---|
|
Cardiopulmonary Exercise Test Parameters (CPET).
Failed Initial CPET
|
5 Participants
|
|
Cardiopulmonary Exercise Test Parameters (CPET).
Withdrew Prior to CPET
|
2 Participants
|
|
Cardiopulmonary Exercise Test Parameters (CPET).
Screenfailed due to Ranolazine Intolerance
|
2 Participants
|
|
Cardiopulmonary Exercise Test Parameters (CPET).
Completed
|
5 Participants
|
Adverse Events
CPET Control / CPET With Ranexa
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPET Control / CPET With Ranexa
n=14 participants at risk
The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy.
|
|---|---|
|
Cardiac disorders
CAD (Ranexa 1000mg BID Treatment)
|
7.1%
1/14 • Number of events 1 • 30 days.
|
|
General disorders
Ranexa Intolerant (Ranexa 1000mg BID Treatment)
|
14.3%
2/14 • Number of events 2 • 30 days.
|
|
General disorders
Headache (Ranexa 1000mg BID Treatment)
|
7.1%
1/14 • Number of events 1 • 30 days.
|
Additional Information
Agostino Ingraldi, MD, FACC
Cardiovascular Institute of the South
Phone: 337-988-1585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place