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

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ClinicalTrials.gov Identifier: NCT00770107
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Luzerner Kantonsspital

Tracking Information
First Submitted Date  ICMJE October 3, 2008
First Posted Date  ICMJE October 9, 2008
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE June 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
Left ventricular ejection fraction [ Time Frame: One day, one week, two weeks, four weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
  • Quality of life [ Time Frame: One day, one week, two week, four weeks ]
  • 6-minutes walking test [ Time Frame: One day, one week, two weeks, four weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
Official Title  ICMJE Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure on Long-term Treatment With Diuretic Drugs
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: Thiamine
    Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks
  • Drug: Placebo
    Placebo, once daily, for a duration of 4 weeks
Study Arms  ICMJE
  • Active Comparator: Thiamine
    Intervention: Drug: Thiamine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 8, 2008)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770107
Other Study ID Numbers  ICMJE Thiamine in Heart Failure
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Paul Erne, Kantonsspital Luzern
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Luzerner Kantonsspital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Luzerner Kantonsspital
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP