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Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial (BEAT HFpEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02885636
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : February 5, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Barry Borlaug, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Congestive Heart Failure
Heart Failure, Left-Sided
Left-Sided Heart Failure
Interventions Drug: Albuterol
Other: Saline placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo Total
Hide Arm/Group Description

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
68  (8) 64  (17) 66  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
6
  40.0%
8
  53.3%
14
  46.7%
Male
9
  60.0%
7
  46.7%
16
  53.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 15 participants 30 participants
33.7  (7) 35.6  (9.2) 34.6  (8.1)
1.Primary Outcome
Title Change in 20 Watt Exercise Pulmonary Vascular Resistance (PVR)
Hide Description The exercise PVR at 20 Watts after study drug relative to the exercise PVR at 20 Watts in the initial assessment prior to study drug. This measurement is made by subtracting pulmonary capillary wedge pressure from the mean pulmonary arterial pressure and dividing by cardiac output in liters per minute and reported as wood units. A decrease in PVR measured by wood units would be considered a favorable response.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: wood units
-0.6  (0.5) 0.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Resting Pulmonary Vascular Resistance
Hide Description The resting PVR after study drug relative to the resting PVR in the initial assessment prior to study drug. This measurement is made by subtracting pulmonary capillary wedge pressure from the mean pulmonary arterial pressure and dividing by cardiac output in liters per minute and reported as wood units.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: wood units
-0.6  (0.5) -0.3  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Exercise Pulmonary Capillary Wedge Pressure (PCWP)
Hide Description Pulmonary capillary wedge pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter. PCWP position was confirmed by appearance on fluoroscopy, characteristic pressure waveforms, and oximetry.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2  (6) -3  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Resting Pulmonary Capillary Wedge Pressure (PCWP)
Hide Description Pulmonary capillary wedge pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter. PCWP position was confirmed by appearance on fluoroscopy, characteristic pressure waveforms, and oximetry.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2  (2) -2  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Exercise Pulmonary Artery Compliance
Hide Description Pulmonary artery compliance was calculated as the ratio of stroke volume/pulmonary artery pulse pressure.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mL/mm Hg
1.6  (1.6) 0.0  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Resting Pulmonary Artery Compliance
Hide Description Pulmonary artery compliance was calculated as the ratio of stroke volume/pulmonary artery pulse pressure.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mL/mm Hg
1.2  (1.0) 0.7  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Exercise Pulmonary Artery Pressure
Hide Description Pulmonary artery pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8  (4) -2  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Change in Resting Pulmonary Artery Pressure
Hide Description Pulmonary artery pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-5  (3) -3  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Change in Exercise Right Atrial Pressure (RA)
Hide Description RA was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-5  (3) -1  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change in Resting Right Atrial Pressure (RA)
Hide Description RA was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg
-3  (2) -1  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Change in Exercise Cardiac Output
Hide Description Cardiac output was calculated using the direct Fick method of breath-by-breath oxygen consumption (V02)/arterial-venous oxygen content difference (AVO2 diff).
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: L/min
2.0  (2.1) 0.1  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Change in Resting Cardiac Output
Hide Description Cardiac output was calculated using the direct Fick method of breath-by-breath oxygen consumption (V02)/arterial-venous oxygen content difference (AVO2 diff).
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: L/min
0.6  (1.2) 0.4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Change in Exercise Pulmonary Elastance
Hide Description Pulmonary elastance was calculated by the ratio of pulmonary artery systolic pressure/stroke volume.
Time Frame Baseline, 10 minutes after intervention during exercise
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg/mL
-0.17  (0.11) -0.05  (0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Change in Resting Pulmonary Elastance
Hide Description Pulmonary elastance was calculated by the ratio of pulmonary artery systolic pressure/stroke volume.
Time Frame Baseline, 10 minutes after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description:

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: mm Hg/mL
-0.11  (0.13) -0.03  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inhaled Albuterol, Inhaled Saline Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Subjects were monitored in the recovery area for up to two hours after procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Albuterol Inhaled Saline Placebo
Hide Arm/Group Description

2.5 mg inhaled albuterol through a high efficiency nebulizer -single dose

Albuterol: : Experimental: Inhaled albuterol

2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose

Inhaled saline through a high efficiency nebulizer -single dose

Saline placebo: Saline inhaled through a nebulizer as a single dose

All-Cause Mortality
Inhaled Albuterol Inhaled Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Inhaled Albuterol Inhaled Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inhaled Albuterol Inhaled Saline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
This was a proof-of-concept study and chronic effects of albuterol were not examined. Further studies testing more clinically meaningful end points are needed to determine whether beta-agonists will improve patient-centric outcomes.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Barry Borlaug
Organization: Mayo Clinic
Phone: 507-284-8846
Responsible Party: Barry Borlaug, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02885636     History of Changes
Other Study ID Numbers: 16-005140A
R01HL128526 ( U.S. NIH Grant/Contract )
R01HL126638 ( U.S. NIH Grant/Contract )
U01HL125205 ( U.S. NIH Grant/Contract )
U10HL110262 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2016
First Posted: August 31, 2016
Results First Submitted: January 13, 2019
Results First Posted: February 5, 2019
Last Update Posted: February 22, 2019