Phase 4
N=12
Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease
Microvascular Angina
Bottom Line
View on ClinicalTrials.gov: NCT01665508 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Seattle Angina Questionnaire Score — 83.3; 29.2; 74.1; 67.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nebivolol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seattle Angina Questionnaire Score |
83.3; 29.2; 74.1; 67.6; 80.0; 70.0 | — |
| SECONDARY Peak VO2 Measured by Cardiopulmonary Exercise Testing |
13.1; 11.0 | — |
| SECONDARY Resource Utilization Questionnaire |
— | — |
| SECONDARY SF36 |
75.0; 67.9; 85.4; 82.3; 75.2; 78.7 | < 0.05 sig |
| SECONDARY Exercise Duration |
11.9; 11.8 | — |
| SECONDARY Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing |
119; 145 | — |
| SECONDARY Peak O2 Pulse |
13.1; 11 | — |
Summary
Women have less significant blockages of coronary arteries, however have greater symptoms and worse outcomes compared to their age-matched male counterparts. This paradox has led to the recognition and importance of the microvasculature ( small vessels) as a contributor to symptoms and outcomes. Nebivolol has unique antioxidant properties and dilates blood vessels and it is therefore proposed that treatment with nebivolol will reduce angina (chest symptoms) in women with microvascular disease as well as improve exercise capacity, reduce resource utilization and improve other measures of artery function.
Eligibility Criteria
Inclusion Criteria
- women between the ages of 40-80
- with evidence of coronary microvascular dysfunction as determined by the presence of rest and or exertional chest tightness and a history of either an elevated troponin level or positive stress test ( EKG criteria or imaging) , as well as non-obstructive coronary artery disease (<50% epicardial obstruction) by either diagnostic catheterization with coronary angiography or CT angiography.
Exclusion Criteria
- Women who cannot tolerate a beta blocker.
- Women receiving Hormone Replacement Therapy
- Women of child-bearing age who are not on a birth-control method.
- Women with inability to exercise.
- Women with left ventricular systolic dysfunction (LVEF less than 40%)
- Women who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
- Women with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Women who are unable to speak, read, and understand English and are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
- Women with any contraindications to beta blocker therapy
- Women with myocardial bridging
- Women with Prinzmetal's angina
Data sourced from ClinicalTrials.gov (NCT01665508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.