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

May 16, 2008
August 12, 2013
January 2008
February 2010   (final data collection date for primary outcome measure)
  • Effect of Thiamine Supplementation on Dyspnea [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.
  • Effect of Thiamine Supplementation on Dyspnea [ Time Frame: 8-Hour ] [ Designated as safety issue: No ]
    Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.
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 ]
Complete list of historical versions of study NCT00680706 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Thiamine and Acute Decompensated Heart Failure: Pilot Study
Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Diabetes
  • Drug: Thiamine
    Thiamine (100 mg) in 50 ml D5W, x 2.
    Other Name: Vitamin B1
  • Drug: Placebo
    D5W (50 ml)
    Other Name: Placebo
  • Experimental: Thiamine
    Receives thiamine
    Intervention: Drug: Thiamine
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
June 2012
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680706
07-059
No
Howard Smithline, Baystate Medical Center
Baystate Medical Center
Beth Israel Deaconess Medical Center
Principal Investigator: Howard Smithline, MD Baystate Medical Center
Baystate Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP