Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: Thiamine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thiamine<br>Thiamine tablets of 300mg are prescribed for 1 months | Drug: Thiamine<br>* 300 mg daily for 30 days<br>* Other names: Thiamine: brand name: Thiamine Hakim;|
| Placebo Comparator: Plascebo<br>Tablets of 300mg placebo are prescribed for 1 months | Drug: Thiamine<br>* 300 mg daily for 30 days<br>* Other names: Thiamine: brand name: Thiamine Hakim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea score | scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thiamine, heart failure