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

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
Nandita Scott, Massachusetts General Hospital Identifier:
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.

Condition Intervention Phase
Microvascular Angina
Drug: Nebivolol
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nebivolol for the Relief of Microvascular Angina in Women

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

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)

Enrollment: 12
Study Start Date: April 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Nebivolol
Patient to start nebivolol and have repeat testing in 3 months
Other Name: Bystolic

  Show Detailed Description


Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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 identifier: NCT01665508

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Principal Investigator: Nandita S Scott, MD Massachusetts General Hospital
Principal Investigator: Malissa J Wood, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Nandita Scott, Co-Director Corrigan Women's Heart Health Program, Massachusetts General Hospital Identifier: NCT01665508     History of Changes
Other Study ID Numbers: BYS-IT-75
Study First Received: August 9, 2012
Last Updated: August 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
cardiopulmonary testing

Additional relevant MeSH terms:
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Signs and Symptoms
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on October 08, 2015