Clinical Trials Directory

Trials / Completed

CompletedNCT00770107

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

Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure on Long-term Treatment With Diuretic Drugs

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (estimated)
Sponsor
Luzerner Kantonsspital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Interventions

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

Timeline

Start date
2004-06-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2008-10-09
Last updated
2011-06-27

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT00770107. Inclusion in this directory is not an endorsement.