Clinical Trial: A Trial of Thiamin Supplementation in Patients With Heart Failure
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized Controlled Trial of the Effect of Thiamin Supplementation on Heart Function in Ambulatory Patients With Heart Failure
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.
Detailed Summary:
Background: There is now accumulating evidence that patients with heart failure (HF) have a high prevalence of thiamin deficiency (TD). Since thiamin is a key cofactor in the enzyme systems that produce energy from both carbohydrates and fats, TD may contribute to the energy depletion frequently observed in the failing heart. Altered energy reserves with a reduction in myocardial ATP have now been recognized to play a critical role in the development and progression of HF. Therefore, correction of TD may enhance cardiac energy substrate availability and utilization, leading to improvement of ventricular function and symptoms.
Primary Hypothesis: The left ventricular ejection fraction in stable, ambulatory patients with systolic heart failure receiving 6 months of oral thiamin supplementation will be significantly higher in comparison with those receiving a placebo.
Secondary Hypothesis: In heart failure patients oral thiamin supplementation will 1)have favourable effects on ventricular remodelling (reduction in diastolic and systolic volumes) and regional function; 2)reduce neurohormonal stimulation (BNP and norepinephrine) as well as oxidative stress; 3)improve exercise capacity and 4)improve symptoms and quality of life.
Ambulatory patients attending heart failure clinics at Mount Sinai, University Health Network, Trillium Health Centre and St. Michael's Hospital with systolic heart failure (NYHA class II-IV, left ventricular ejection fraction <45%) will be screened for eligibility to participate in our randomized trial. We will randomize seventy eligible patients using a stratified, permuted block randomization scheme, to be given either 100mg BID of thiamin HCl or a matching placebo BID in a 1:1 ratio to be taken for six months. All study personnel will be blinded to
Sponsor: St. Michael's Hospital, Toronto
Current Primary Outcome: Left ventricular ejection fraction measured by CMR or 3D echo at 6 months [ Time Frame: 6 months ]
Original Primary Outcome: Left ventricular ejection fraction measured by CMR at 6 months [ Time Frame: 6 months ]
Current Secondary Outcome:
- LV volume, regional function as measure by CMR tagging [ Time Frame: 6 months ]
- Exercise tolerance - distance walked in the standard six-minute walk test [ Time Frame: 6 months ]
- Levels of circulating BNP, norepinephrine and F2-isoprostanes [ Time Frame: 6 months ]
- Scores on the Living with Heart Failure quality of life instrument [ Time Frame: 6 months ]
- Prevalence of TD in an ambulatory HF population [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: St. Michael's Hospital, Toronto
Dates:
Date Received: August 13, 2009
Date Started: September 2009
Date Completion:
Last Updated: December 1, 2015
Last Verified: November 2015
