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Thiamine and Acute Decompensated Heart Failure: Pilot Study

Primary Purpose

Heart Failure, Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thiamine
Placebo
Sponsored by
Baystate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of heart failure on a loop diuretic.
  2. Worsening dyspnea over the past 24 hours.
  3. Currently dyspneic sitting or supine, on or off oxygen.
  4. Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department.
  5. Elevated NT pro-BNP (>450).
  6. Able to communicate in English or Spanish.
  7. Able and willing to provide informed consent.
  8. Age > 18 years.
  9. A primary admitting diagnosis of acute decompensated heart failure.

Exclusion Criteria:

  1. Renal failure on dialysis.
  2. Severe valvular disease.
  3. EKG criteria for acute myocardial infarction (ST segment elevation > 1mm on two contiguous leads).
  4. Initial troponin elevated.
  5. Ventricular arrhythmia (ventricular tachycardia or fibrillation).
  6. Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute.
  7. Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable
  8. Taking a daily fatty acid supplement.
  9. Pregnancy as determined by standard serum or urine b-HCG assay.

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Baystate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thiamine

Control

Arm Description

Receives thiamine

Outcomes

Primary Outcome Measures

Effect of Thiamine Supplementation on Dyspnea
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.
Effect of Thiamine Supplementation on Dyspnea
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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
August 12, 2013
Sponsor
Baystate Medical Center
Collaborators
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00680706
Brief Title
Thiamine and Acute Decompensated Heart Failure: Pilot Study
Official Title
Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baystate Medical Center
Collaborators
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids. We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thiamine
Arm Type
Experimental
Arm Description
Receives thiamine
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Thiamine
Other Intervention Name(s)
Vitamin B1
Intervention Description
Thiamine (100 mg) in 50 ml D5W, x 2.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
D5W (50 ml)
Primary Outcome Measure Information:
Title
Effect of Thiamine Supplementation on Dyspnea
Description
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.
Time Frame
Baseline
Title
Effect of Thiamine Supplementation on Dyspnea
Description
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.
Time Frame
8-Hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of heart failure on a loop diuretic. Worsening dyspnea over the past 24 hours. Currently dyspneic sitting or supine, on or off oxygen. Radiographic cephalization of vessels. This criteria is not needed if the patient has no other reason for being dyspneic after being evaluated in the emergency department. Elevated NT pro-BNP (>450). Able to communicate in English or Spanish. Able and willing to provide informed consent. Age > 18 years. A primary admitting diagnosis of acute decompensated heart failure. Exclusion Criteria: Renal failure on dialysis. Severe valvular disease. EKG criteria for acute myocardial infarction (ST segment elevation > 1mm on two contiguous leads). Initial troponin elevated. Ventricular arrhythmia (ventricular tachycardia or fibrillation). Supraventricular arrhythmia (atrial fibrillation / flutter) with a ventricular rate >120 beats per minute. Taking a daily thiamine supplementation (any multivitamin or specific thiamine supplementation within the past 2 weeks. Fortified foods, such as cereals, are acceptable Taking a daily fatty acid supplement. Pregnancy as determined by standard serum or urine b-HCG assay.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Smithline, MD
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31060559
Citation
Smithline HA, Donnino M, Blank FSJ, Barus R, Coute RA, Knee AB, Visintainer P. Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial. BMC Complement Altern Med. 2019 May 6;19(1):96. doi: 10.1186/s12906-019-2506-8.
Results Reference
derived

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Thiamine and Acute Decompensated Heart Failure: Pilot Study

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