Trial Outcomes & Findings for Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging (NCT NCT04130438)
NCT ID: NCT04130438
Last Updated: 2025-02-25
Results Overview
Effectiveness of beta blockers and calcium channel blockers for reducing angina in patients with a Myocardial Bridge (MB) compared to placebo determined after 30 days on the study drug by a change in angina, as assessed by the Seattle Angina Questionnaire (SAQ). The SAQ assesses 5 domains: physical limitation, angina stability angina frequency, treatment satisfaction, and quality of life. Each domain score is normalized to a range of 0 to 100, with higher scores corresponding to better outcomes.
TERMINATED
PHASE2
5 participants
baseline and 30 days
2025-02-25
Participant Flow
Participant milestones
| Measure |
Beta Blocker (Nebivolol)
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
|
Overall Study
Had at Least 1 Post-baseline Visit
|
2
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Beta Blocker (Nebivolol)
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy of Medical Therapy in Women and Men With Angina and Myocardial Bridging
Baseline characteristics by cohort
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=2 Participants
Participants receive placebo once a day for 30 days.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 30 daysPopulation: Participants with data at the respective time point
Effectiveness of beta blockers and calcium channel blockers for reducing angina in patients with a Myocardial Bridge (MB) compared to placebo determined after 30 days on the study drug by a change in angina, as assessed by the Seattle Angina Questionnaire (SAQ). The SAQ assesses 5 domains: physical limitation, angina stability angina frequency, treatment satisfaction, and quality of life. Each domain score is normalized to a range of 0 to 100, with higher scores corresponding to better outcomes.
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=2 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Physical limitation - baseline
|
44.4 score on a scale
Standard Deviation 24.4
|
62.2 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
53.4 score on a scale
Standard Deviation 15.6
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Physical limitation - 30 days
|
53.6 score on a scale
Standard Deviation 24.5
|
68.0 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
17.8 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Angina stability - baseline
|
40 score on a scale
Standard Deviation 0
|
40 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
80 score on a scale
Standard Deviation 20
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Angina stability - 30 days
|
50 score on a scale
Standard Deviation 30
|
60 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
20 score on a scale
Standard Deviation 0
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Angina frequency - baseline
|
70 score on a scale
Standard Deviation 0
|
60 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
75 score on a scale
Standard Deviation 25
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Angina frequency - 30 days
|
80 score on a scale
Standard Deviation 10
|
80 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
30 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Treatment satisfaction - baseline
|
67.7 score on a scale
Standard Deviation 8.9
|
100 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
76.5 score on a scale
Standard Deviation 5.85
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Treatment satisfaction - 30 days
|
64.7 score on a scale
Standard Deviation 11.8
|
94.1 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
29.4 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Quality of life - baseline
|
41.6 score on a scale
Standard Deviation 25
|
41.7 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
37.5 score on a scale
Standard Deviation 20.9
|
|
Change in Angina Score Assessed by the Seattle Angina Questionnaire (SAQ)
Quality of life - 30 days
|
54.1 score on a scale
Standard Deviation 20.9
|
58.3 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
25 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
SECONDARY outcome
Timeframe: baseline, 30 daysPopulation: Participants with data at the respective time point
Changes in exercise capacity will be measured by difference in exercise time increment between the groups. The Duke treadmill score is calculated as exercise time × (5 × ST-segment deviation) - (4 × exercise angina), with 0 = no angina, 1 = non-limiting angina, and 2 = exercise-limiting angina. Possible scores range from -25 (highest risk) to +15 (lowest risk). Scores are reported by the number of participants in each risk category: low risk (≥+5), moderate risk (-10 to +4) and high risk (≤-11) (Shaw, et al, 1998).
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=2 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Duke Treadmill Score by Risk Category
Low risk - baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Duke Treadmill Score by Risk Category
Moderate risk - baseline
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Duke Treadmill Score by Risk Category
High risk - baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Duke Treadmill Score by Risk Category
Low risk - 30 days
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Duke Treadmill Score by Risk Category
Moderate risk - 30 days
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Duke Treadmill Score by Risk Category
High risk - 30 days
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline, 30 daysPopulation: Participants with data at the respective time point
The Duke treadmill score is calculated as exercise time × (5 × ST-segment deviation) - (4 × exercise angina), with 0 = no angina, 1 = non-limiting angina, and 2 = exercise-limiting angina. Possible scores range from -25 (highest risk) to +15 (lowest risk).
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=2 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Duke Treadmill Score
Baseline
|
2.3 score on a scale
Standard Deviation 2.35
|
3.0 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
1.5 score on a scale
Standard Deviation 4.95
|
|
Duke Treadmill Score
30 days
|
2 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
10 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
-11 score on a scale
Standard Deviation NA
Standard deviation not calculable for n of 1
|
SECONDARY outcome
Timeframe: 30 days, 6 monthsPopulation: Participants with data at the respective time point
Major adverse cardiovascular events include death, heart attack, coronary stent or bypass surgery, and stroke.
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=1 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Number of Participants With Cardiac Events
30 days
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Cardiac Events
6 months
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Participants with data through 30 days
Percentage of drug taken by participants, measured by pill count at the end of 30 days.
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=1 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Drug Adherence.
|
99.5 percentage of drug taken
Standard Deviation 0.5
|
100 percentage of drug taken
Standard Deviation NA
Standard deviation not calculable for n of 1
|
100 percentage of drug taken
Standard Deviation NA
Standard deviation not calculable for n of 1
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Participants with data at 30 days
Patient self-reported side effects recorded in a diary to be turned in at 30 days. In addition, patients are requested to contact us regarding any serious side effects during the study. Finally, patients are asked about any side effects they experienced during their 30-day follow-up to ensure that symptoms are captured.
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=1 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Number of Participants With Side Effects
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants with data at 6 months
Number of participants who stayed on the study drug at the initial dose, stayed on the study drug at a different dose, switched to an alternate therapy, and/or underwent further cardiac testing.
Outcome measures
| Measure |
Beta Blocker (Nebivolol)
n=2 Participants
Participants receive oral beta blocker (nebivolol 2.5 mg) once a day for 30 days.
|
Calcium Channel Blocker (Diltiazem)
n=1 Participants
Participants receive oral calcium channel blocker (Diltiazem-SR 120 mg) once a day for 30 days.
|
Placebo
n=1 Participants
Participants receive placebo once a day for 30 days.
|
|---|---|---|---|
|
Treatment Course
Switched to alternate therapy
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Treatment Course
Underwent further cardiac testing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Course
Stayed on study drug at the initial dose
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Treatment Course
Stayed on study drug at a different dose
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Beta Blocker (Nebivolol)
Calcium Channel Blocker (Diltiazem)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place