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

NCT01665508 | Completed Phase 4 Results DMC

• 1 other identifier: BYS-IT-75
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microvascular Angina

Keywords

angina; cardiopulmonary testing; metabolomics; nebivolol

Outcome Measures

Primary Outcomes (1)

• Seattle Angina Questionnaire Score

  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.

  3 months

Secondary Outcomes (6)

• Peak VO2 Measured by Cardiopulmonary Exercise Testing

  3 months

• Resource Utilization Questionnaire

  3 months

• SF36

  baseline and 12 week follow-up

• Exercise Duration

  3 months

• Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing

  3 months

Study Arms (1)

Nebivolol

EXPERIMENTAL

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

Interventions

Nebivolol DRUG

Patient to start nebivolol and have repeat testing in 3 months

Also known as: Bystolic

Nebivolol

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Forest Laboratories: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Microvascular Angina; Angina Pectoris

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Nandita S. Scott
• Organization: Massachusetts General Hospital

nsscott@partners.org

6177241739

Study Officials

• Nandita S Scott, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Malissa J Wood, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Corrigan Women's Heart Health Program

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 15, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2016-12

Locations

US (1)