Thiamine and Acute Decompensated Heart Failure: Pilot Study

NCT00680706 | Completed Phase 2 Results

• 1 other identifier: 07-059
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Thiamine

EXPERIMENTAL

Receives thiamine

Drug: Thiamine

Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Thiamine DRUG

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

Also known as: Vitamin B1

Thiamine

Placebo DRUG

D5W (50 ml)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baystate Medical Center: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

• Smithline HA, Donnino M, Blank FSJ, Barus R, Coute RA, Knee AB, Visintainer P. Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial. BMC Complement Altern Med. 2019 May 6;19(1):96. doi: 10.1186/s12906-019-2506-8.

  PMID: 31060559 DERIVED

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Howard Smithline
• Organization: Baystate Medical Center

howard.smithline@baystatehealth.org

413-794-3433

Study Officials

• Howard Smithline, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Emergency Medicine Research

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2012
• Last Updated: August 21, 2013
• Results First Posted: September 28, 2012

Record last verified: 2013-08

Locations

US (2)