Trial Outcomes & Findings for Thiamine and Acute Decompensated Heart Failure: Pilot Study (NCT NCT00680706)

Results Overview

Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

131 participants

Primary outcome timeframe

Baseline

Results posted on

2013-08-21

Participant Flow

Recruitment: January 2008 to February 2010 Location: Emergency Department

One subject was dropped by the PI after consent but before randomization because the subject did not meet the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Thiamine Receives thiamine, 100 mg intravenously at baseline (time 0-hour) and again at time 24-hour.	Control Receives placebo
Overall Study STARTED	70	60
Overall Study COMPLETED	63	55
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thiamine and Acute Decompensated Heart Failure: Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thiamine n=70 Participants Receives thiamine	Control n=60 Participants Receives placebo	Total n=130 Participants Total of all reporting groups
Age Continuous	73 years STANDARD_DEVIATION 13 • n=5 Participants	73 years STANDARD_DEVIATION 13 • n=7 Participants	73 years STANDARD_DEVIATION 13 • n=5 Participants
Sex/Gender, Customized Male	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants
Sex/Gender, Customized Female	33 participants n=5 Participants	27 participants n=7 Participants	60 participants n=5 Participants
Sex/Gender, Customized Unknown	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.

Outcome measures

Outcome measures
Measure	Control n=55 Participants Placebo	Thiamine n=63 Participants
Effect of Thiamine Supplementation on Dyspnea	34 mm Interval 28.0 to 40.0	32 mm Interval 26.0 to 37.0

PRIMARY outcome

Timeframe: 8-Hour

Sitting Upright on Oxygen. Measured using a 10-centimeter visual analog scale (VAS). Measures are in units of millimeters (mm). A smaller number should be interpreted as a less dyspnea. A larger number should be interpreted as a more dyspnea. Less dyspnea is a better clinical outcome than more dyspnea.

Outcome measures

Outcome measures
Measure	Control n=55 Participants Placebo	Thiamine n=63 Participants
Effect of Thiamine Supplementation on Dyspnea	19 mm Interval 12.0 to 26.0	28 mm Interval 22.0 to 34.0

Adverse Events

Thiamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Howard Smithline

Baystate Medical Center

Phone: 413-794-3433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place