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Completed

NCT Number: NCT00680706

Thiamine and Acute Decompensated Heart Failure: Pilot Study

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Thiamine

Drug

Thiamine (100 mg) in 50 ml D5W, x 2.

Other names: Vitamin B1

Placebo

Drug

D5W (50 ml)

Primary outcomes

  1. Effect of Thiamine Supplementation on Dyspnea

    Time frame: Baseline

    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.

  2. Effect of Thiamine Supplementation on Dyspnea

    Time frame: 8-Hour

    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.

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
May 20, 2008
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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