A Trial of Thiamin Supplementation in Patients With Heart Failure

NCT00959075 | Completed Phase 4 DMC

• 1 other identifier: NA6617
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Patients with heart failure (HF) are at increased risk of developing thiamin deficiency (TD). Thiamin (vitamin B1) is required for the production of energy and therefore TD may contribute to the energy depletion commonly observed in the failing heart. Thiamin supplementation trials to date have shown conflicting results and therefore further studies to explain the impact of thiamin supplementation on HF patients with TD is necessary. Objective: The purpose of this study is to determine whether thiamin supplementation in an ambulatory cohort of patients with systolic heart failure will provide any benefit in terms of improved heart function, symptoms, exercise capacity, and quality of life. Description: Patients involved in the study will be given either thiamin supplements or a matching placebo (pills containing no thiamin) for 6 months. The ability of the heart to pump before and after the supplementation will be measured using cardiac magnetic resonance imaging (MRI)and/or 3D echocardiography. Relevance: This study will determine whether thiamin supplementation improves cardiac function, exercise tolerance and quality of life. Thiamin supplementation is widely available, inexpensive, and safe. Therefore this trial may have a major impact on the optimal management of the expanding population of heart failure patients.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction measured by CMR or 3D echo at 6 months

  6 months

Secondary Outcomes (5)

• LV volume, regional function as measure by CMR tagging

  6 months

• Exercise tolerance - distance walked in the standard six-minute walk test

  6 months

• Levels of circulating BNP, norepinephrine and F2-isoprostanes

  6 months

• Scores on the Living with Heart Failure quality of life instrument

  6 months

• Prevalence of TD in an ambulatory HF population

  6 months

Study Arms (2)

Oral thiamin supplementation

EXPERIMENTAL

Vitamin B1 (Oral thiamin) 100mg BID for 6 months

Dietary Supplement: Vitamin B1

Sugar pill

PLACEBO COMPARATOR

oral placebo 1 tablet BID for 6 months

Dietary Supplement: Placebo

Interventions

Vitamin B1 DIETARY_SUPPLEMENT

100 mg Twice a day

Also known as: Jamieson - Thiamin Mononitrate

Oral thiamin supplementation

Placebo DIETARY_SUPPLEMENT

Sugar pill

Sugar pill

Eligibility Criteria

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

You may qualify if:

• primary diagnosis of ischemic, dilated, idiopathic or valvular heart failure characterized by an ejection fraction of \< 45% (echocardiography or radionuclide scan)
• have an optimized medication regimen (ACE inhibitor or angiotensin receptor blocker, and beta blocker at target doses, or up-titrated to the maximum doses as tolerated)
• been stable (on current medication regimen with no hospitalizations for acute decompensated heart failure \> 2 months) prior to entry into the study

You may not qualify if:

• unable or unwilling to provide informed consent
• have any concurrent condition which would result in thiamin deficiency, namely gastrointestinal disorders, magnesium deficiency, liver disease, thyrotoxicosis, B12 deficiency, folate deficiency, prolonged diarrhoeal disease, dialysis, prolonged fever or infection, recent myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary artery bypass surgery within 3 months), or renal failure
• are rapidly deteriorating, who are not on a stable medication regimen (2 months or more) or who have been hospitalized for acute decompensated heart failure in the last 2 months
• are on experimental medications
• are taking vitamin supplements containing thiamin \>10mg/day
• consume excessive alcohol (\> 3 drinks per day), have a documented history of alcoholism or have documented alcoholic cardiomyopathy
• have permanent atrial fibrillation
• are pregnant or would like to become pregnant
• have a right-to-left, bidirectional, or transient right to left cardiac shunts
• have clinically suspected wet Beri Beri in the opinion of the treating physician

Sponsors & Collaborators

• Unity Health Toronto: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Niagara North Family Health Team

St. Catharines, Ontario, L2R 1R5, Canada

Location

Related Publications (1)

• Keith M, Quach S, Ahmed M, Azizi-Namini P, Al-Hesayen A, Azevedo E, James R, Leong-Poi H, Ong G, Desjardins S, Lee PJ, Ravamehr-Lake D, Yan AT. Thiamin supplementation does not improve left ventricular ejection fraction in ambulatory heart failure patients: a randomized controlled trial. Am J Clin Nutr. 2019 Dec 1;110(6):1287-1295. doi: 10.1093/ajcn/nqz192.

  PMID: 31504093 DERIVED

MeSH Terms

Conditions

Heart Failure; Beriberi

Interventions

Thiamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mary E. Keith, PhD, RD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

CA (1)