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Thiamine and Acute Decompensated Heart Failure: Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Howard Smithline, Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00680706
First received: May 16, 2008
Last updated: August 12, 2013
Last verified: August 2013
Results First Received: July 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Diabetes
Interventions: Drug: Thiamine
Drug: Placebo

  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
Recruitment: January 2008 to February 2010 Location: Emergency Department

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was dropped by the PI after consent but before randomization because the subject did not meet the inclusion/exclusion criteria.

Reporting Groups
  Description
Thiamine Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.
Control Receives placebo

Participant Flow:   Overall Study
    Thiamine   Control
STARTED   70   60 
COMPLETED   63   55 
NOT COMPLETED   7   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
Thiamine Receives thiamine
Control Receives placebo
Total Total of all reporting groups

Baseline Measures
   Thiamine   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   60   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 73  (13)   73  (13)   73  (13) 
Gender, Customized 
[Units: Participants]
     
Male   34   33   67 
Female   33   27   60 
Unknown   3   0   3 


  Outcome Measures
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1.  Primary:   Effect of Thiamine Supplementation on Dyspnea   [ Time Frame: Baseline ]

2.  Primary:   Effect of Thiamine Supplementation on Dyspnea   [ Time Frame: 8-Hour ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Howard Smithline
Organization: Baystate Medical Center
phone: 413-794-3433
e-mail: howard.smithline@baystatehealth.org



Responsible Party: Howard Smithline, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00680706     History of Changes
Other Study ID Numbers: 07-059
Study First Received: May 16, 2008
Results First Received: July 27, 2012
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board