Study to Evaluate Effect of Nebivolol on Angina in Women With Microvascular Disease (NIRVANA)
This study has been completed.
Information provided by (Responsible Party):
Nandita Scott, Massachusetts General Hospital
First received: August 9, 2012
Last updated: August 17, 2015
Last verified: August 2015
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Nebivolol for the Relief of Microvascular Angina in Women
Primary Outcome Measures:
- Seattle Angina Questionnaire Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- peak VO2 measured by cardiopulmonary exercise testing [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Assessment of exercise capacity (peak VO2) as determined by CPET, additional fitness parameters will include: VO2 at the anaerobic threshold, peak work-load, time-to-angina, aerobic efficiency and O2 pulse)
- resource utilization questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
widely used questionnaire used as a measure of health status will be obtained at baseline ( standardized care ) and follow-up ( 3 months on nebivolol)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||40 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665508
|Massachusetts General Hospital
|Boston, Massachusetts, United States, 02114 |
Massachusetts General Hospital
||Nandita S Scott, MD
||Massachusetts General Hospital
||Malissa J Wood, MD
||Massachusetts General Hospital
No publications provided
||Nandita Scott, Co-Director Corrigan Women's Heart Health Program, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 9, 2012
||August 17, 2015
||United States: Food and Drug Administration
Keywords provided by Massachusetts General Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 06, 2015
Signs and Symptoms
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs