Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure
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Purpose
Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Drug: Thiamine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Left ventricular ejection fraction [ Time Frame: One day, one week, two weeks, four weeks ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: One day, one week, two week, four weeks ] [ Designated as safety issue: No ]
- 6-minutes walking test [ Time Frame: One day, one week, two weeks, four weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2004 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided by Luzerner Kantonsspital
Additional 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 |
| Study First Received: | October 3, 2008 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Thiamine Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013