Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine whether levothyroxine supplementation is beneficial in patients with systolic heart failure and subclinical hypothyroidism on the functional class evaluated with a 6 minute walk test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2014
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
May 10, 2013
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 16, 2014
December 1, 2014
6 months
May 10, 2013
December 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Performance at the 6 minutes walk test
6 months
Secondary Outcomes (7)
Difference of the brain natriuretic peptide measurement
6 months
Difference of activin a measurement
6 months
Difference of myostatin measurement
6 months
Increase in heart rate measurement
6 months
Difference of systolic and diastolic function on transthoracic echocardiogram
6 months
- +2 more secondary outcomes
Study Arms (1)
Levothyroxine
EXPERIMENTALLevothyroxine supplementation
Interventions
T4 supplementation for heart failure patients with subclinical hypothyroidism.
Eligibility Criteria
You may qualify if:
- Biochemical diagnosis of subclinical hypothyroidism (TSH between 3.5 and 10 with a normal T4)
- Systolic heart failure with New-York Heart Association (NYHA) class II or III
- Left ventricular ejection fraction under 40%
- Stable heart failure for the past 3 months (no IV furosemide or hospital admission)
- Beta-blockers and ACE inhibitors titrated to the maximum tolerated dose
You may not qualify if:
- Isolated diastolic heart failure
- Awaiting cardiac resynchronisation therapy
- Impossibility to perform the 6 minutes walk test
- Active cancer / Life expectancy under 18 months
- Treatment with amiodarone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michel Nguyen, MD
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
May 10, 2013
First Posted
December 15, 2014
Study Start
December 1, 2014
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
December 16, 2014
Record last verified: 2014-12