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

This study has been completed.
Sponsor:
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00770107
First received: October 3, 2008
Last updated: June 22, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: One day, one week, two weeks, four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770107

Locations
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
  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 July 20, 2014