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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
Results First Received: September 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Microvascular Angina
Intervention: Drug: Nebivolol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Nebivolol: Patient to start nebivolol and have repeat testing in 3 months


Participant Flow:   Overall Study
    Nebivolol
STARTED   12 
COMPLETED   7 
NOT COMPLETED   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Nebivolol: Patient to start nebivolol and have repeat testing in 3 months


Baseline Measures
   Nebivolol 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seattle Angina Questionnaire Score   [ Time Frame: 3 months ]

2.  Secondary:   Peak VO2 Measured by Cardiopulmonary Exercise Testing   [ Time Frame: 3 months ]

3.  Secondary:   Resource Utilization Questionnaire   [ Time Frame: 3 months ]

4.  Secondary:   SF36   [ Time Frame: baseline and 12 week follow-up ]

5.  Secondary:   Exercise Duration   [ Time Frame: 3 months ]

6.  Secondary:   Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing   [ Time Frame: 3 months ]

7.  Secondary:   Peak O2 Pulse   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nandita S. Scott
Organization: Massachusetts General Hospital
phone: 6177241739
e-mail: nsscott@partners.org



Responsible Party: Nandita Scott, 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