Status:
COMPLETED
Thiamine and Acute Decompensated Heart Failure: Pilot Study
Lead Sponsor:
Baystate Medical Center
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Heart Failure
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ree...
Eligibility Criteria
Inclusion
- History of heart failure on a loop diuretic.
- Worsening dyspnea over the past 24 hours.
- Currently dyspneic sitting or supine, on or off oxygen.
- Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
- Elevated NT pro-BNP (\>450).
- Able to communicate in English or Spanish.
- Able and willing to provide informed consent.
- Age \> 18 years.
- A primary admitting diagnosis of acute decompensated heart failure.
Exclusion
- Renal failure on dialysis.
- Severe valvular disease.
- EKG criteria for acute myocardial infarction (ST segment elevation \> 1mm on two contiguous leads).
- Initial troponin elevated.
- Ventricular arrhythmia (ventricular tachycardia or fibrillation).
- Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate \>120 beats per minute.
- Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable
- Taking a daily fatty acid supplement.
- Pregnancy as determined by standard serum or urine b-HCG assay.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00680706
Start Date
January 1 2008
End Date
June 1 2012
Last Update
August 21 2013
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Baystate Medical Center
Springfield, Massachusetts, United States, 01199