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History of Changes for Study: NCT00770107
Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
Latest version (submitted June 22, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 8, 2008 None (earliest Version on record)
2 June 22, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Identification
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Study NCT00770107
Submitted Date:  October 8, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: Thiamine in Heart Failure
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2008
Overall Status: Recruiting
Study Start: June 2004
Primary Completion: December 2009 [Anticipated]
Study Completion:
First Submitted: October 3, 2008
First Submitted that
Met QC Criteria:
October 8, 2008
First Posted: October 9, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 8, 2008
Last Update Posted: October 9, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Luzerner Kantonsspital
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Open or close this module Conditions
Conditions: Heart Failure
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Thiamine Drug: Thiamine
Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo, once daily, for a duration of 4 weeks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Left ventricular ejection fraction
[ Time Frame: One day, one week, two weeks, four weeks ]

Secondary Outcome Measures:
1. Quality of life
[ Time Frame: One day, one week, two week, four weeks ]

2. 6-minutes walking test
[ Time Frame: One day, one week, two weeks, four weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Paul Erne, MD
Telephone: ++41 (0)41 205 5106
Email: Paul.Erne@KSL.CH
Locations: Switzerland
Kantonsspital Luzern
[Recruiting]
Luzern, Switzerland, 6000
Contact:Contact: Renate Schoenenberger, MD ++41 (0)41 205 1947 Renate.Schoenenberger@KSL.CH
Contact:Principal Investigator: Paul Erne, MD
Contact:Sub-Investigator: Renate Schoenenberger, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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