Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

This study has been completed.
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01115504
First received: May 3, 2010
Last updated: December 22, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Chronic Heart Failure
Drug: Thiamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • Dyspnea score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention


Secondary Outcome Measures:
  • Edema score [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention

  • Systolic function [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.


Estimated Enrollment: 50
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mehdi Mousavi, Azad university
ClinicalTrials.gov Identifier: NCT01115504     History of Changes
Other Study ID Numbers: THF
Study First Received: May 3, 2010
Last Updated: December 22, 2010
Health Authority: Iran: Ethics Committee

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014