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Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Sponsor
Mashhad University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01115504
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
7
Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated 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 1, 2010
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thiamine

Thiamine tablets of 300mg are prescribed for 1 months

Drug: Thiamine
300 mg daily for 30 days
Other Names:
  • 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 Names:
  • Thiamine: brand name: Thiamine Hakim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Edema score [30 days]

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

    2. Systolic function [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01115504
    Other Study ID Numbers:
    • THF
    First Posted:
    May 4, 2010
    Last Update Posted:
    Dec 23, 2010
    Last Verified:
    Nov 1, 2010
    Keywords provided by , ,
    Thiamine
    heart failure
    Additional relevant MeSH terms:
    Heart Failure
    Thiamine

    Study Results

    No Results Posted as of Dec 23, 2010