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

Systolic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02316743
• Other study ID #: Thyroid-001
• Status: Recruiting
• Phase: Phase 4
• First received: May 10, 2013
• Last updated: December 13, 2014
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2014
• Source: Université de Sherbrooke
• Contact: Michel Nguyen, MD
• Phone: 819-346-1110
• Email: michel.nguyen[@]usherbrooke.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Hypothyroidism
• Sub-clinical Hypothyroidism
• Systolic Heart Failure

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance at the 6 minutes walk test		6 months	No
Secondary	Difference of the brain natriuretic peptide measurement		6 months	No
Secondary	Difference of activin a measurement		6 months	No
Secondary	Difference of myostatin measurement		6 months	No
Secondary	Increase in heart rate measurement	Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months	6 months	Yes
Secondary	Difference of systolic and diastolic function on transthoracic echocardiogram		6 months	No
Secondary	Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)		6 months	Yes
Secondary	Normalisation of thyroid workup		6 months	No