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

NCT ID: NCT02316743

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Systolic Heart Failure Sub-clinical Hypothyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levothyroxine

Levothyroxine supplementation

Group Type EXPERIMENTAL

Levothyroxine supplementation

Intervention Type DRUG

T4 supplementation for heart failure patients with subclinical hypothyroidism.

Interventions

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Levothyroxine supplementation

T4 supplementation for heart failure patients with subclinical hypothyroidism.

Intervention Type DRUG

Other Intervention Names

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T4 supplementation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Paul Farand

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel Nguyen, MD

Role: STUDY_DIRECTOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Michel Nguyen, MD

Role: CONTACT

Phone: 819-346-1110

Email: [email protected]

Facility Contacts

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Etienne L. Couture, MD

Role: primary

Other Identifiers

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Thyroid-001

Identifier Type: -

Identifier Source: org_study_id