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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

About this trial

This is an interventional treatment trial for Systolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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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