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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

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Thiamine Drug: Placebo Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure on Long-term Treatment With Diuretic Drugs
Study Start Date : June 2004
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770107


Locations
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Erne, Kantonsspital Luzern
ClinicalTrials.gov Identifier: NCT00770107     History of Changes
Other Study ID Numbers: Thiamine in Heart Failure
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs