Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Phase 3

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: Thiamine

• Registration Number: NCT01115504
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plascebo	Thiamine	Tablets of 300mg placebo are prescribed for 1 months
Thiamine	Thiamine	Thiamine tablets of 300mg are prescribed for 1 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of medicine, Azad university; 🇮🇷 Shahrood, Semnan, Iran, Islamic Republic of