Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

December 22, 2010 updated by: Mashhad University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema score
Time Frame: 30 days
Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention
30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Chair: Mehdi Mousavi, Cardiologist, Azad university
  • Study Director: Said Namazi, MD, Azad university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 23, 2010

Last Update Submitted That Met QC Criteria

December 22, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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