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Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart (BORG)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
AstraZeneca
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01798992
First received: February 22, 2013
Last updated: December 27, 2016
Last verified: December 2016
Results First Received: June 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Idiopathic Dilated Cardiomyopathy
Interventions: Drug: Carvedilol
Drug: Metoprolol succinate
Drug: Metoprolol succinate + doxazosin

  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
Patients were recruited between 9/1/2000 and 3/1/2008 from outpatient general cardiology and heart failure specialty clinics at the University of Colorado Hospital and University of Utah Health Sciences Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
65 patients met screening criteria and provided consent. Exclusions included personal preference (4), administrative reasons such as relocation (2), normalization of LVEF prior to assignment (2), and lack of central venous access (1).

Reporting Groups
  Description
Non-failing Control Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
Metoprolol Succinate

Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months

Metoprolol succinate

Metoprolol Succinate + Doxazosin

Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months

Metoprolol succinate + doxazosin

Carvedilol

Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months

Carvedilol


Participant Flow:   Overall Study
    Non-failing Control   Metoprolol Succinate   Metoprolol Succinate + Doxazosin   Carvedilol
STARTED   4   19   16   17 
COMPLETED   4   17   14   16 
NOT COMPLETED   0   2   2   1 
Administrative withdrawal                0                1                0                1 
Lost to Follow-up                0                1                1                0 
Insufficient biopsy tissue                0                0                1                0 



  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.
Patients who gave informed consent and underwent baseline imaging and endomyocardial biopsy.

Reporting Groups
  Description
Non-failing Control Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
Metoprolol Succinate

Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months

Metoprolol succinate

Metoprolol Succinate + Doxazosin

Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months

Metoprolol succinate + doxazosin

Carvedilol

Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months

Carvedilol

Total Total of all reporting groups

Baseline Measures
   Non-failing Control   Metoprolol Succinate   Metoprolol Succinate + Doxazosin   Carvedilol   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   19   16   17   56 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 41.0  (17.1)   45.9  (13.6)   46.0  (7.5)   44.9  (15.1)   45.3  (12.8) 
[1] Calculated using enrollment date - birthdate
Gender 
[Units: Participants]
Count of Participants
         
Female      1  25.0%      4  21.1%      6  37.5%      5  29.4%      16  28.6% 
Male      3  75.0%      15  78.9%      10  62.5%      12  70.6%      40  71.4% 
Race/Ethnicity, Customized 
[Units: Participants]
         
European Ancestry   4   15   9   13   41 
African Ancestry   0   1   4   0   5 
Hispanic   0   2   1   4   7 
Other   0   1   2   0   3 
Region of Enrollment 
[Units: Participants]
         
United States   4   19   16   17   56 
LV ejection fraction [1] 
[Units: %]
Mean (Standard Deviation)
 58.8  (7.4)   22.5  (7.1)   28.5  (8.7)   28.6  (8.7)   28.6  (11.9) 
[1] Left ventricular ejection fraction = Stroke volume/End diastolic volume. Measured by single-photon emitted computed tomographic (SPECT) imaging or where not available, clinical multi-gated acquisition (MUGA) radionuclide ventriculography


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Left Ventricular Ejection Fraction (LVEF) at 12 Months   [ Time Frame: 12 months ]

2.  Secondary:   Improvement in LVEF at 3 Months   [ Time Frame: 3 months ]

3.  Secondary:   Composite of All-cause Mortality, Need for Heart Transplant or Need for Ventricular Assist Device.   [ Time Frame: 18 months ]

4.  Other Pre-specified:   Change in Myocardial Gene Expression at 3 Months   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Change in Myocardial Gene Expression at 12 Months   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   Change in Myocardial microRNA Expression at 3 Months   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Change in Myocardial microRNA Expression at 12 Months   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Bristow, MD PhD
Organization: University of Colorado, Denver
phone: 303-724-5453
e-mail: Michael.Bristow@ucdenver.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01798992     History of Changes
Other Study ID Numbers: 00-0242
2R01HL048013 ( US NIH Grant/Contract Award Number )
Study First Received: February 22, 2013
Results First Received: June 6, 2016
Last Updated: December 27, 2016