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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770107
• Other study ID #: Thiamine in Heart Failure
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: June 22, 2011
• Start date: June 2004
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Thiamine
Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks
• Placebo
Placebo, once daily, for a duration of 4 weeks

Locations

Country	Name	City	State
Switzerland	Kantonsspital Luzern	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction		One day, one week, two weeks, four weeks	No
Secondary	Quality of life		One day, one week, two week, four weeks	No
Secondary	6-minutes walking test		One day, one week, two weeks, four weeks	No