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

Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systolic Heart Failure; Sub-clinical Hypothyroidism

Intervention: Levothyroxine supplementation (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Université de Sherbrooke

Official(s) and/or principal investigator(s):
Michel Nguyen, MD, Study Director, Affiliation: Centre Hospitalier Universitaire de Sherbrooke

Overall contact:
Michel Nguyen, MD, Phone: 819-346-1110, Ext: 70323, Email: michel.nguyen@usherbrooke.ca

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.

Clinical Details

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

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

Primary outcome: Performance at the 6 minutes walk test

Secondary outcome:

Difference of the brain natriuretic peptide measurement

Difference of activin a measurement

Difference of myostatin measurement

Increase in heart rate measurement

Difference of systolic and diastolic function on transthoracic echocardiogram

Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)

Normalisation of thyroid workup

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Michel Nguyen, MD, Phone: 819-346-1110, Ext: 70323, Email: michel.nguyen@usherbrooke.ca

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting
Etienne L. Couture, MD, Phone: 819-346-1110, Ext: 74326, Email: etienne.couture@usherbroke.ca
Etienne L. Couture, MD, Sub-Investigator
Michel Nguyen, MD, Principal Investigator
Paul Farand, MD, Sub-Investigator
Andre Carpentier, MD, Sub-Investigator
Denise St-Cyr Tribble, PhD, Sub-Investigator
Serge Lepage, MD, Sub-Investigator
Mannix Auger-Messier, PhD, Sub-Investigator
Additional Information

Starting date: December 2014
Last updated: December 13, 2014

Page last updated: August 23, 2015

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