Recruiting

Levothyroxine

Sponsor:

Université de Sherbrooke

Code:

NCT02316743

Conditions

Systolic Heart Failure

Sub-clinical Hypothyroidism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Levothyroxine supplementation

Study Details

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.

Conditions

Systolic Heart Failure

Sub-clinical Hypothyroidism

Study ID

NCT02316743

Start date

Dec, 2014

Status verified date

Dec, 2014

Completion date

Jul, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Levothyroxine

Levothyroxine supplementation

Interventions

Levothyroxine supplementation

T4 supplementation for heart failure patients with subclinical hypothyroidism.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michel Nguyen, MD

819-346-1110michel.nguyen@usherbrooke.ca

Locations

Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Etienne L. Couture, MD

819-346-1110etienne.couture@usherbroke.ca

Principal Investigator:

Michel Nguyen, MD

More Information

Sponsor

Université de Sherbrooke

Last update posted

Dec 16, 2014

Last verified

Dec, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2014-12-16.