NCT00770107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

5.5 years

First QC Date

October 3, 2008

Last Update Submit

June 22, 2011

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction

    One day, one week, two weeks, four weeks

Secondary Outcomes (2)

  • Quality of life

    One day, one week, two week, four weeks

  • 6-minutes walking test

    One day, one week, two weeks, four weeks

Study Arms (2)

Thiamine

ACTIVE COMPARATOR
Drug: Thiamine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ThiamineDRUG

Supplementation of thiamine (vitamin b1) 300 mg per day, once daily, for a duration of 4 weeks

Thiamine
PlaceboDRUG

Placebo, once daily, for a duration of 4 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable congestive heart failure on a prescription for diuretic drugs

You may not qualify if:

  • Acute heart failure
  • Foreseeable need for further changes in medication
  • Current medication containing vitamins
  • Patients with a creatinine above 250 μmol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 22057652DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 9, 2008

Study Start

June 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

CH(1)