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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00770107
Enrollment
12
Registered
2008-10-09
Start date
2004-06-30
Completion date
2009-12-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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.

Interventions

DRUGThiamine

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

DRUGPlacebo

Placebo, once daily, for a duration of 4 weeks

Sponsors

Luzerner Kantonsspital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fractionOne day, one week, two weeks, four weeks

Secondary

MeasureTime frame
Quality of lifeOne day, one week, two week, four weeks
6-minutes walking testOne day, one week, two weeks, four weeks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026