Thiamine and Acute Decompensated Heart Failure: Pilot Study
Condition: Heart Failure; Diabetes
MeSH terms: Heart Failure
Intervention: Thiamine; Placebo
Intervention description: Thiamine (100 mg) in 50 ml D5W, x 2.; D5W (50 ml)
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of heart failure on a loop diuretic.

          2. Worsening dyspnea over the past 24 hours.

          3. Currently dyspneic sitting or supine, on or off oxygen.

          4. 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.

          5. Elevated NT pro-BNP (>450).

          6. Able to communicate in English or Spanish.

          7. Able and willing to provide informed consent.

          8. Age > 18 years.

          9. A primary admitting diagnosis of acute decompensated heart failure.

        Exclusion Criteria:

          1. Renal failure on dialysis.

          2. Severe valvular disease.

          3. EKG criteria for acute myocardial infarction (ST segment elevation > 1mm on two
             contiguous leads).

          4. Initial troponin elevated.

          5. Ventricular arrhythmia (ventricular tachycardia or fibrillation).

          6. Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate
             >120 beats per minute.

          7. Taking a daily thiamine supplementation (any multivitamin or specific thiamine
             supplementation within the past 2 weeks. Fortified foods, such as cereals, are
             acceptable

          8. Taking a daily fatty acid supplement.

          9. Pregnancy as determined by standard serum or urine b-HCG assay.