Thiamine and Acute Decompensated Heart Failure: Pilot Study
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| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2008 | ||||
| Last Updated Date | August 29, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Calculate the magnitude of the effect of thiamine supplementation on change in: FFA,BNP,dyspnea,arrhythmias. [ Time Frame: 8 hours ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00680706 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Describe the relationships between thiamine levels and above measures. Describe the relationship between FFA, and composite arrhythmias. [ Time Frame: 8, 32 hours ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Thiamine and Acute Decompensated Heart Failure: Pilot Study | ||||
| Official Title ICMJE | Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients. | ||||
| Brief Summary | Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids. We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 131 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00680706 | ||||
| Other Study ID Numbers ICMJE | 07-059 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Howard Smithline, Baystate Medical Center | ||||
| Study Sponsor ICMJE | Baystate Medical Center | ||||
| Collaborators ICMJE | Beth Israel Deaconess Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | Baystate Medical Center | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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