Thiamine and Acute Decompensated Heart Failure: Pilot Study

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680706
• Other study ID #: 07-059
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: August 12, 2013
• Start date: January 2008
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Heart Failure

Intervention

Drug:
• Thiamine
Thiamine (100 mg) in 50 ml D5W, x 2.
• Placebo
D5W (50 ml)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Baystate Medical Center	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Thiamine Supplementation on Dyspnea	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.	Baseline	No
Primary	Effect of Thiamine Supplementation on Dyspnea	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.	8-Hour	No