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Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

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ClinicalTrials.gov Identifier: NCT01115504
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : December 23, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Thiamine Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Thiamine
Thiamine tablets of 300mg are prescribed for 1 months
Drug: Thiamine
300 mg daily for 30 days
Other Name: Thiamine: brand name: Thiamine Hakim
Placebo Comparator: Plascebo
Tablets of 300mg placebo are prescribed for 1 months
Drug: Thiamine
300 mg daily for 30 days
Other Name: Thiamine: brand name: Thiamine Hakim



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115504


Locations
Iran, Islamic Republic of
Faculty of medicine, Azad university
Shahrood, Semnan, Iran, Islamic Republic of
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Chair: Mehdi Mousavi, Cardiologist Azad university
Study Director: Said Namazi, MD Azad university

Responsible Party: Mehdi Mousavi, Azad university
ClinicalTrials.gov Identifier: NCT01115504     History of Changes
Other Study ID Numbers: THF
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: November 2010

Keywords provided by Mashhad University of Medical Sciences:
Thiamine
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs