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

Université de Sherbrooke

Status and phase: Unknown; Phase 4

Conditions: Systolic Heart Failure; Sub-clinical Hypothyroidism

Treatments: Drug: Levothyroxine supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02316743

Thyroid-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Levothyroxine

Experimental group

Description:

Levothyroxine supplementation

Treatment:

Drug: Levothyroxine supplementation