Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism

Phase 4

• Conditions: Systolic Heart Failure; Sub-clinical Hypothyroidism
• Interventions: Drug: Levothyroxine supplementation

• Registration Number: NCT02316743
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Study First Submitted: 2013-05-10
• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-10
• Last Update Submitted: 2014-12-13
• Study First Posted: 2014-12-15
• Last Update Posted: 2014-12-16
• Primary Completion: 2015-06
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levothyroxine	Levothyroxine supplementation	Levothyroxine supplementation

Primary Outcome Measures

Name	Time	Method
Performance at the 6 minutes walk test	6 months

Secondary Outcome Measures

Name	Time	Method
Normalisation of thyroid workup	6 months
Difference of activin a measurement	6 months
Difference of myostatin measurement	6 months
Difference of systolic and diastolic function on transthoracic echocardiogram	6 months
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)	6 months
Difference of the brain natriuretic peptide measurement	6 months
Increase in heart rate measurement	6 months	Absence / Presence of tachycardia (heart rate \> 100 beat per minute) at baseline and 6 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada