Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-12-31

Brief Summary

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Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.

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Detailed Description

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In the treatment of congestive heart failure, diuretic drugs have become a firm cornerstone of therapy. Up to 50% of patients with congestive heart failure in industrialized nations will undergo long-term diuretic treatment. Diuretic therapy is associated with a loss of water soluble vitamins, including vitamin B1 (thiamine). Electrolyte dysbalance, a major side effect of diuretic therapy, has been extensively studied. In sharp contrast, only few data are available about the effects of vitamin loss and in particular of thiamine in this setting. Available data suggest that a diuretic treatment is associated with an increased risk for thiamine deficiency. Thiamine plays a crucial role for normal cardiac function, since severe thiamine deficiency leads to congestive heart failure (wet beriberi). Consequently, patients undergoing diuretic treatment might have compromised heart function. Supplementation of thiamine has been reported to improve cardiac function in patients with congestive heart failure on long-term treatment with diuretic drugs. However, no efforts have been made to confirm those preliminary observations by a placebo-controlled, double-blind study.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Thiamine

Group Type ACTIVE_COMPARATOR

Thiamine

Intervention Type DRUG

Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, once daily, for a duration of 4 weeks

Interventions

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Thiamine

Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks

Intervention Type DRUG

Placebo

Placebo, once daily, for a duration of 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with stable congestive heart failure on a prescription for diuretic drugs

Exclusion Criteria

* Acute heart failure
* Foreseeable need for further changes in medication
* Current medication containing vitamins
* Patients with a creatinine above 250 μmol/l

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No