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

• Sponsor: Luzerner Kantonsspital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00770107
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Thiamine; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2004
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Left ventricular ejection fraction [One day, one week, two weeks, four weeks]

Secondary Outcome Measures

1. Quality of life [One day, one week, two week, four weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Luzern	Luzern		Switzerland	6000

Sponsors and Collaborators

• Luzerner Kantonsspital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00770107
• Other Study ID Numbers: Thiamine in Heart Failure
• First Posted: Oct 9, 2008
• Last Update Posted: Jun 27, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Heart Failure; Thiamine

Study Results

No Results Posted as of Jun 27, 2011