Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
Primary Purpose
Systolic Heart Failure, Sub-clinical Hypothyroidism
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Levothyroxine supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Systolic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier Universitaire de SherbrookeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levothyroxine
Arm Description
Levothyroxine supplementation
Outcomes
Primary Outcome Measures
Performance at the 6 minutes walk test
Secondary Outcome Measures
Difference of the brain natriuretic peptide measurement
Difference of activin a measurement
Difference of myostatin measurement
Increase in heart rate measurement
Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months
Difference of systolic and diastolic function on transthoracic echocardiogram
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)
Normalisation of thyroid workup
Full Information
NCT ID
NCT02316743
First Posted
May 10, 2013
Last Updated
December 13, 2014
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT02316743
Brief Title
Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
Official Title
Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Forty patients with systolic heart failure and subclinical hypothyroidism will be include in a open label trial. They will receive levothyroxine supplementation to determine if their functional class will be affect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure, Sub-clinical Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine
Arm Type
Experimental
Arm Description
Levothyroxine supplementation
Intervention Type
Drug
Intervention Name(s)
Levothyroxine supplementation
Other Intervention Name(s)
T4 supplementation
Intervention Description
T4 supplementation for heart failure patients with subclinical hypothyroidism.
Primary Outcome Measure Information:
Title
Performance at the 6 minutes walk test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference of the brain natriuretic peptide measurement
Time Frame
6 months
Title
Difference of activin a measurement
Time Frame
6 months
Title
Difference of myostatin measurement
Time Frame
6 months
Title
Increase in heart rate measurement
Description
Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months
Time Frame
6 months
Title
Difference of systolic and diastolic function on transthoracic echocardiogram
Time Frame
6 months
Title
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)
Time Frame
6 months
Title
Normalisation of thyroid workup
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Nguyen, MD
Phone
819-346-1110
Ext
70323
Email
michel.nguyen@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Nguyen, MD
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne L. Couture, MD
Phone
819-346-1110
Ext
74326
Email
etienne.couture@usherbroke.ca
First Name & Middle Initial & Last Name & Degree
Etienne L. Couture, MD
First Name & Middle Initial & Last Name & Degree
Michel Nguyen, MD
First Name & Middle Initial & Last Name & Degree
Paul Farand, MD
First Name & Middle Initial & Last Name & Degree
Andre Carpentier, MD
First Name & Middle Initial & Last Name & Degree
Denise St-Cyr Tribble, PhD
First Name & Middle Initial & Last Name & Degree
Serge Lepage, MD
First Name & Middle Initial & Last Name & Degree
Mannix Auger-Messier, PhD
12. IPD Sharing Statement
Learn more about this trial
Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
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