NCT01115504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 23, 2010

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

May 3, 2010

Last Update Submit

December 22, 2010

Conditions

Chronic Heart Failure

Keywords

Thiamineheart failure

Outcome Measures

Primary Outcomes (1)

  • Dyspnea score

    scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention

    30 days

Secondary Outcomes (2)

  • Edema score

    30 days

  • Systolic function

    30 days

Study Arms (2)

Thiamine

EXPERIMENTAL

Thiamine tablets of 300mg are prescribed for 1 months

Drug: Thiamine

Plascebo

PLACEBO COMPARATOR

Tablets of 300mg placebo are prescribed for 1 months

Drug: Thiamine

Interventions

ThiamineDRUG

300 mg daily for 30 days

Also known as: Thiamine: brand name: Thiamine Hakim
PlasceboThiamine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
  • Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.

You may not qualify if:

  • Decompensated heart failure
  • Renal failure
  • COPD
  • Asthma
  • Uncontrolled hypertension
  • Bradycardia or tachycardia which needs increase or decrease in medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Azad university

Shahrood, Semnan Province, Iran

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Mehdi Mousavi, Cardiologist

    Azad university

    STUDY CHAIR

  • Said Namazi, MD

    Azad university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

December 23, 2010

Record last verified: 2010-11

Locations

IR(1)