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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Nandita Scott, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01665508
First received: August 9, 2012
Last updated: March 8, 2017
Last verified: December 2016
  Purpose
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: No masking
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 Nandita Scott, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01665508

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

Responsible Party: Nandita Scott, Co-Director Corrigan Women's Heart Health Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01665508     History of Changes
Other Study ID Numbers: BYS-IT-75
Study First Received: August 9, 2012
Results First Received: September 12, 2016
Last Updated: March 8, 2017

Keywords provided by Nandita Scott, Massachusetts General Hospital:
angina
cardiopulmonary testing
metabolomics
nebivolol

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017