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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
Luzerner Kantonsspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 3, 2008
Last Updated
June 22, 2011
Sponsor
Luzerner Kantonsspital
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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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