Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease (NIRVANA)
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|ClinicalTrials.gov Identifier: NCT01665508|
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Microvascular Angina||Drug: Nebivolol||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nebivolol for the Relief of Microvascular Angina in Women|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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.
Patient to start nebivolol and have repeat testing in 3 months
Other Name: Bystolic
- Seattle Angina Questionnaire Score [ Time Frame: 3 months ]
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.
- Peak VO2 Measured by Cardiopulmonary Exercise Testing [ Time Frame: 3 months ]Assessment of exercise capacity (peak VO2) as determined by CPET
- Resource Utilization Questionnaire [ Time Frame: 3 months ]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
- SF36 [ Time Frame: baseline and 12 week follow-up ]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.
- Exercise Duration [ Time Frame: 3 months ]Assessment of exercise duration as determined by CPET
- Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing [ Time Frame: 3 months ]Assessment of peak heart rate as determined by CPET
- Peak O2 Pulse [ Time Frame: 3 months ]peak O2 pulse as measured by cardiopulmonary exercise testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665508
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Nandita S Scott, MD||Massachusetts General Hospital|
|Principal Investigator:||Malissa J Wood, MD||Massachusetts General Hospital|