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

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
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: May 13, 2013
Last verified: May 2013
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Nebivolol for the Relief of Microvascular Angina in Women

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

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)


Estimated Enrollment: 70
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (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:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women between the ages of 45-80
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665508

Contacts
Contact: Nandita S Scott, MD 617 724 1739 nsscott@partners.org
Contact: Malissa J Wood, MD 617 724 1986 mjwood@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nandita S Scott, MD     617-724-1739     nsscott@partners.org    
Sub-Investigator: Aaron Baggish, MD            
Principal Investigator: Malissa J Wood, MD            
Principal Investigator: Nandita S Scott, MD            
Sub-Investigator: Gregory Lewis, MD            
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

No publications provided

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
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 23, 2013