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

Overview

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 Title of Study: “Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

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.

Interventions

  • Drug: Levothyroxine supplementation
    • T4 supplementation for heart failure patients with subclinical hypothyroidism.

Arms, Groups and Cohorts

  • Experimental: Levothyroxine
    • Levothyroxine supplementation

Clinical Trial Outcome Measures

Primary Measures

  • Performance at the 6 minutes walk test
    • Time Frame: 6 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Université de Sherbrooke
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul Farand, Investigator – Université de Sherbrooke
  • Overall Official(s)
    • Michel Nguyen, MD, Study Director, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  • Overall Contact(s)
    • Michel Nguyen, MD, 819-346-1110, michel.nguyen@usherbrooke.ca

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