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Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Thiamine
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Thiamine, heart failure

Eligibility Criteria

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

Inclusion Criteria:

  • Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
  • Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.

Exclusion Criteria:

  • Decompensated heart failure
  • Renal failure
  • COPD
  • Asthma
  • Uncontrolled hypertension
  • Bradycardia or tachycardia which needs increase or decrease in medications

Sites / Locations

  • Faculty of medicine, Azad university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thiamine

Plascebo

Arm Description

Thiamine tablets of 300mg are prescribed for 1 months

Tablets of 300mg placebo are prescribed for 1 months

Outcomes

Primary Outcome Measures

Dyspnea score
scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention

Secondary Outcome Measures

Edema score
Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention
Systolic function
ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.

Full Information

First Posted
May 3, 2010
Last Updated
December 22, 2010
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01115504
Brief Title
Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
Official Title
Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.
Detailed Description
The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle. Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Thiamine, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thiamine
Arm Type
Experimental
Arm Description
Thiamine tablets of 300mg are prescribed for 1 months
Arm Title
Plascebo
Arm Type
Placebo Comparator
Arm Description
Tablets of 300mg placebo are prescribed for 1 months
Intervention Type
Drug
Intervention Name(s)
Thiamine
Other Intervention Name(s)
Thiamine: brand name: Thiamine Hakim
Intervention Description
300 mg daily for 30 days
Primary Outcome Measure Information:
Title
Dyspnea score
Description
scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Edema score
Description
Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention
Time Frame
30 days
Title
Systolic function
Description
ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) Optimal medical therapy according to the present guidelines for at least 3 months before enrollment. Exclusion Criteria: Decompensated heart failure Renal failure COPD Asthma Uncontrolled hypertension Bradycardia or tachycardia which needs increase or decrease in medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Mousavi, Cardiologist
Organizational Affiliation
Azad university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Said Namazi, MD
Organizational Affiliation
Azad university
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine, Azad university
City
Shahrood
State/Province
Semnan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

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