Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
NCT ID: NCT01115504
Last Updated: 2010-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2010-05-31
2010-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Thiamine
Thiamine tablets of 300mg are prescribed for 1 months
Thiamine
300 mg daily for 30 days
Plascebo
Tablets of 300mg placebo are prescribed for 1 months
Thiamine
300 mg daily for 30 days
Interventions
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Thiamine
300 mg daily for 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.
Exclusion Criteria
* Renal failure
* COPD
* Asthma
* Uncontrolled hypertension
* Bradycardia or tachycardia which needs increase or decrease in medications
ALL
No
Sponsors
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Mashhad University of Medical Sciences
OTHER
Responsible Party
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Azad university
Principal Investigators
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Mehdi Mousavi, Cardiologist
Role: STUDY_CHAIR
Azad university
Said Namazi, MD
Role: STUDY_DIRECTOR
Azad university
Locations
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Faculty of medicine, Azad university
Shahrood, Semnan Province, Iran
Countries
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Other Identifiers
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THF
Identifier Type: -
Identifier Source: org_study_id