Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Heart Failure

Treatments: Drug: Thiamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01115504

THF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Thiamine

Experimental group

Description:

Thiamine tablets of 300mg are prescribed for 1 months

Treatment:

Drug: Thiamine

Plascebo

Placebo Comparator group

Description:

Tablets of 300mg placebo are prescribed for 1 months

Treatment:

Drug: Thiamine