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

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ClinicalTrials.gov Identifier: NCT02316743
Recruitment Status : Unknown
Verified December 2014 by Paul Farand, Université de Sherbrooke.
Recruitment status was:  Recruiting
First Posted : December 15, 2014
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Paul Farand, Université de Sherbrooke

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.

Condition or disease Intervention/treatment Phase
Systolic Heart Failure Sub-clinical Hypothyroidism Drug: Levothyroxine supplementation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
Study Start Date : December 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levothyroxine
Levothyroxine supplementation
Drug: Levothyroxine supplementation
T4 supplementation for heart failure patients with subclinical hypothyroidism.
Other Name: T4 supplementation




Primary Outcome Measures :
  1. Performance at the 6 minutes walk test [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Difference of the brain natriuretic peptide measurement [ Time Frame: 6 months ]
  2. Difference of activin a measurement [ Time Frame: 6 months ]
  3. Difference of myostatin measurement [ Time Frame: 6 months ]
  4. Increase in heart rate measurement [ Time Frame: 6 months ]
    Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months

  5. Difference of systolic and diastolic function on transthoracic echocardiogram [ Time Frame: 6 months ]
  6. Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization) [ Time Frame: 6 months ]
  7. Normalisation of thyroid workup [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316743


Contacts
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Contact: Michel Nguyen, MD 819-346-1110 ext 70323 michel.nguyen@usherbrooke.ca

Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Etienne L. Couture, MD    819-346-1110 ext 74326    etienne.couture@usherbroke.ca   
Sub-Investigator: Etienne L. Couture, MD         
Principal Investigator: Michel Nguyen, MD         
Sub-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         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Study Director: Michel Nguyen, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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Responsible Party: Paul Farand, Investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02316743     History of Changes
Other Study ID Numbers: Thyroid-001
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Hypothyroidism
Heart Diseases
Cardiovascular Diseases
Thyroid Diseases
Endocrine System Diseases