Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Thiamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Kantonsspital Luzern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Thiamine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
Secondary Outcome Measures
Quality of life
6-minutes walking test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770107
Brief Title
Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
Official Title
Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure on Long-term Treatment With Diuretic Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Luzerner Kantonsspital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thiamine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Thiamine
Intervention Description
Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, once daily, for a duration of 4 weeks
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Time Frame
One day, one week, two weeks, four weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
One day, one week, two week, four weeks
Title
6-minutes walking test
Time Frame
One day, one week, two weeks, four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kantonsspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22057652
Citation
Schoenenberger AW, Schoenenberger-Berzins R, der Maur CA, Suter PM, Vergopoulos A, Erne P. Thiamine supplementation in symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled, cross-over pilot study. Clin Res Cardiol. 2012 Mar;101(3):159-64. doi: 10.1007/s00392-011-0376-2. Epub 2011 Nov 5.
Results Reference
derived
Learn more about this trial
Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
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