Trial Outcomes & Findings for Ivabradine in the Management of Cardiac Autonomic Dysfunction Associated With Thoracic Radiation Therapy. (NCT NCT03137537)
NCT ID: NCT03137537
Last Updated: 2022-02-10
Results Overview
Calculate the change in resting HR (from Holter monitor data) from baseline to 6 weeks for each patient in the study. Then compare the median change with ivabradine to the median change with placebo.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-02-10
Participant Flow
Participant milestones
| Measure |
Ivabradine
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ivabradine
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Baseline echo data not available in 2 pts randomized to the ivabradine group
Baseline characteristics by cohort
| Measure |
Ivabradine
n=12 Participants
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
n=11 Participants
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=12 Participants
|
52 years
n=11 Participants
|
56 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=12 Participants
|
10 Participants
n=11 Participants
|
19 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
21 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Beta-blocker at baseline
|
6 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
12 Participants
n=23 Participants
|
|
Ejection Fraction, %
|
61 %
n=10 Participants • Baseline echo data not available in 2 pts randomized to the ivabradine group
|
63 %
n=11 Participants • Baseline echo data not available in 2 pts randomized to the ivabradine group
|
63 %
n=21 Participants • Baseline echo data not available in 2 pts randomized to the ivabradine group
|
|
Resting heart rate
|
90 bpm
n=12 Participants
|
93 bpm
n=11 Participants
|
91 bpm
n=23 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Analyzed all patients who had data available at baseline and at 6 weeks
Calculate the change in resting HR (from Holter monitor data) from baseline to 6 weeks for each patient in the study. Then compare the median change with ivabradine to the median change with placebo.
Outcome measures
| Measure |
Ivabradine
n=12 Participants
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
n=10 Participants
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
|---|---|---|
|
To Investigate Whether Ivabradine Lowers Resting HR, Compared To Placebo, In Survivors Of Lymphoma
|
-13 bpm
Interval -25.0 to 0.0
|
-1 bpm
Interval -13.0 to 13.0
|
SECONDARY outcome
Timeframe: 6 weeksCalculate the change in exercise duration (from exercise treadmill stress tests) from baseline to 6 weeks for each patient in the study. Then compare the median change in exercise duration with ivabradine to the median change in exercise duration with placebo.
Outcome measures
| Measure |
Ivabradine
n=12 Participants
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
n=10 Participants
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
|---|---|---|
|
To Evaluate Whether Ivabradine Improves Exercise Duration, Compared To Placebo, In Survivors Of Lymphoma
|
0.4 minutes
Interval -2.7 to 2.6
|
-0.1 minutes
Interval -1.0 to 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksCalculate the change in cardiac autonomic function (from cardiac autonomic function testing) from baseline to 6 weeks in one half of the patients in the study (n=30)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksCalculate the change in health related quality of life (from SF-36 quality of life surveys) from baseline to 6 weeks for each patient in the study (n=60)
Outcome measures
Outcome data not reported
Adverse Events
Ivabradine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Oral Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivabradine
n=12 participants at risk
* Ivabradine will be administered for a total of 6 weeks
* Ivabradine is taken orally twice daily
* Dosage will be adjusted according to physician determination
Ivabradine: lower heart rate in heart failure patients.
|
Placebo Oral Tablet
n=11 participants at risk
* Placebo will be administered for a total of 6 weeks
* Placebo is taken orally twice daily
* Dosage will be adjusted according to physician determination
Placebo Oral Tablet: Procedure prescribed to compare the active effect of a medicine.
|
|---|---|---|
|
Cardiac disorders
heart failure
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
|
Cardiac disorders
sinus bradycardia
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
|
General disorders
fatigue
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/12 • 6 weeks
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/12 • 6 weeks
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
8.3%
1/12 • Number of events 1 • 6 weeks
|
0.00%
0/11 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place