Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Chronic Heart Failure Clinical Trial

Official title:

Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115504
• Other study ID #: THF
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2010
• Last updated: December 22, 2010
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Thiamine
300 mg daily for 30 days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of medicine, Azad university	Shahrood	Semnan

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea score	scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention	30 days	No
Secondary	Edema score	Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention	30 days	No
Secondary	Systolic function	ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.	30 days	No