Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01115504

Enrollment

Registered

2010-05-04

Start date

2010-05-31

Completion date

2010-12-31

Last updated

2010-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

Thiamine, heart failure

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.

Interventions

DRUGThiamine

300 mg daily for 30 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026