The Prevalence of Thiamin Deficiency in Ambulatory Patients With Heart Failure

NCT00953823 | Completed

• 1 other identifier: REB 09-031
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with heart failure are at an increased risk for thiamin deficiency (TD), for many reasons such as malnutrition and the use of diuretic drugs. Thiamin is a B vitamin that plays an important role in the production of energy in body. Therefore, low levels of thiamin may limit the amount of energy available for the heart to pump blood. Recent thiamin supplementation trials have demonstrated significant improvements in heart function. However, while clinically important, the results of these studies are limited by their small sample sizes, indirect measurement of thiamin status and reliance on hospitalized patients. Therefore, the investigators' goal is to determine the prevalence of thiamin deficiency in ambulatory patients with heart failure by direct measurement of thiamin in red blood cells.

Conditions

Heart Failure

Keywords

Thiamin supplementation; Thiamin deficiency; Heart failure; Heart function; Vitamin B1 supplementation

Outcome Measures

Primary Outcomes (1)

• Prevalence of Thiamin deficiency as determined by Erythrocyte thiamin pyrophosphate (TPP) measured using a direct HPLC technique

  baseline

Secondary Outcomes (3)

• Eligible patients will be randomized to one of three commercially available doses of oral thiamin hydrochloride; 50 mg QD, 50 mg BID and 100 mg BID. They will take the supplements for 2 weeks.

  baseline to after two weeks of supplementation

• Plasma samples will be analyzed for the plasma levels of NE, BNP, F2-isoprostanes

  baseline and after supplementation

• Urinary excretion of thiamin following the 2 week supplementation period.

  by the end of two-week supplementation period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiology Clinic (St Michael's Hospital)

You may qualify if:

• Patients with the primary diagnosis of ischemic, dilated, idiopathic or valvular HF characterized by an ejection fraction of \< 45% (echocardiography or radionuclide scan)
• Patients with NYHA class I-IV symptoms

You may not qualify if:

• Patients who are unable or unwilling to provide informed consent
• Patients with any concurrent condition which would result in TD, namely, gastrointestinal disorders (Crohn's disease, ulcerative colitis), liver disease, prolonged diarrhoeal disease, dialysis, prolonged fever, infection or renal failure
• Patients who are rapidly deteriorating, who are not on a stable medication regimen (≥ 2 months) or have been hospitalized for acute decompensated HF in the last 2 months
• Patients who are on experimental medications
• Patients who consume excessive alcohol (\> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
• Patients who are pregnant

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Foundation for Dietetic Research (CFDR): collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood test

MeSH Terms

Conditions

Heart Failure; Beriberi

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Thiamine Deficiency; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mary Keith, PhD, RD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Andrew Yan, MD

  Cardiologist, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

• Abdul Al-Hesayen, MD

  Cardiologist, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Nutrition and Dietetic Education/Research

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

CA (1)