Trial Outcomes & Findings for Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease (NCT NCT01665508)

Results Overview

Seattle Angina Questionnaire (SAQ): The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease. The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-100, with higher scores indicating a better health status.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2017-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Nebivolol Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
Overall Study STARTED	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nebivolol n=12 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	61.6 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 7 patients complete baseline and followup data reported below is anginal stability

Seattle Angina Questionnaire (SAQ): The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease. The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-100, with higher scores indicating a better health status.

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
Seattle Angina Questionnaire Score anginal stability	83.3 units on a scale Standard Deviation 25.8	29.2 units on a scale Standard Deviation 18.8
Seattle Angina Questionnaire Score phyisical limitation	74.1 units on a scale Standard Deviation 18.0	67.6 units on a scale Standard Deviation 21.1
Seattle Angina Questionnaire Score anginal frequency	80.0 units on a scale Standard Deviation 20.0	70.0 units on a scale Standard Deviation 15.5
Seattle Angina Questionnaire Score treatment satisfaction	81.3 units on a scale Standard Deviation 18.5	84.4 units on a scale Standard Deviation 13.0
Seattle Angina Questionnaire Score qualify of life	62.5 units on a scale Standard Deviation 33.6	51.4 units on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: 3 months

Assessment of exercise capacity (peak VO2) as determined by CPET

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
Peak VO2 Measured by Cardiopulmonary Exercise Testing	13.1 ml/beat Standard Deviation 2.3	11.0 ml/beat Standard Deviation 2.5

SECONDARY outcome

Timeframe: 3 months

Population: data was not collected

Resource utilization as determined by patient phone calls, office visits, emergency room visits, and number of hospitalizations, as well an index cost for any hospitalizations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 12 week follow-up

Population: physical functioning reported below

The SF-36v2 is a commonly used instrument to assess HRQoL8. The questionnaire evaluates 8 HRQoL domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The physical component score is a composite of the SF-36v2 physical health domains (physical functioning, role-physical, bodily pain and general health) and the mental component score a composite of the mental health domains (vitality, social functioning, role-emotional and mental health). Each HRQoL domain score ranges from 0 to 100, with higher scores corresponding to a better health status. The SF-36v2 domain scores were calculated using the QualityMetric Health Outcomes Scoring Software version 4.5.

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
SF36 physical functioning	75.0 units on a scale Standard Deviation 13.8	67.9 units on a scale Standard Deviation 10.8
SF36 role-physical	85.4 units on a scale Standard Deviation 12.9	82.3 units on a scale Standard Deviation 16
SF36 bodily pain	75.2 units on a scale Standard Deviation 19.9	78.7 units on a scale Standard Deviation 22.8
SF36 general health	75 units on a scale Standard Deviation 12.6	72.8 units on a scale Standard Deviation 11.1
SF36 vitality	67.7 units on a scale Standard Deviation 14.5	63.5 units on a scale Standard Deviation 15
SF36 social functioning	91.7 units on a scale Standard Deviation 10.2	91.7 units on a scale Standard Deviation 15.1
SF36 role-emotional	90.3 units on a scale Standard Deviation 15.3	97.2 units on a scale Standard Deviation 16.8
SF36 mental health	81.7 units on a scale Standard Deviation 6.1	81.7 units on a scale Standard Deviation 9.3
SF36 physical component	50.3 units on a scale Standard Deviation 4.9	48.4 units on a scale Standard Deviation 6.3
SF36 mental component	55.3 units on a scale Standard Deviation 5	56.7 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 3 months

Assessment of exercise duration as determined by CPET

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
Exercise Duration	11.9 minutes Standard Deviation 1.1	11.8 minutes Standard Deviation 1.9

SECONDARY outcome

Timeframe: 3 months

Assessment of peak heart rate as determined by CPET

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing	119 beats per minute Standard Deviation 11	145 beats per minute Standard Deviation 17

SECONDARY outcome

Timeframe: 3 months

peak O2 pulse as measured by cardiopulmonary exercise testing

Outcome measures

Outcome measures
Measure	Nebivolol n=7 Participants Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment. Nebivolol: Patient to start nebivolol and have repeat testing in 3 months There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)	Baseline n=7 Participants results prior to nebivolol start
Peak O2 Pulse	13.1 ml/beat Standard Deviation 2.3	11 ml/beat Standard Deviation 2.5

Adverse Events

Nebivolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nandita S. Scott

Massachusetts General Hospital

Phone: 6177241739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place