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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Diabetes
Drug: Thiamine
Drug: Placebo
Phase 2

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
Official Title: Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 131
Study Start Date: January 2008
Study Completion Date: June 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thiamine
Receives thiamine
Drug: Thiamine
Thiamine (100 mg) in 50 ml D5W, x 2.
Other Name: Vitamin B1
Placebo Comparator: Control Drug: Placebo
D5W (50 ml)
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00680706

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Howard Smithline, MD Baystate Medical Center
  More Information

No publications provided

Responsible Party: Howard Smithline, Chief, Emergency Medicine Research, 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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014