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Completed

NCT Number: NCT01115504

Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

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.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of medicine, Azad university

Shahrood, Semnan Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine

Drug

300 mg daily for 30 days

Other names: Thiamine: brand name: Thiamine Hakim

Primary outcomes

  1. Dyspnea score

    Time frame: 30 days

    scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention

Secondary outcomes

  1. Edema score

    Time frame: 30 days

    Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention

  2. Systolic function

    Time frame: 30 days

    ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 4, 2010
Registry last updated
Dec 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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