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

Sponsor
Université de Sherbrooke (Other)
Overall Status
Unknown status
CT.gov ID
NCT02316743
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
7
Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
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 :
Dec 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levothyroxine

Levothyroxine supplementation

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Performance at the 6 minutes walk test [6 months]

    Secondary Outcome Measures

    1. Difference of the brain natriuretic peptide measurement [6 months]

    2. Difference of activin a measurement [6 months]

    3. Difference of myostatin measurement [6 months]

    4. Increase in heart rate measurement [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 [6 months]

    6. Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization) [6 months]

    7. Normalisation of thyroid workup [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

    Sponsors and Collaborators

    • Université de Sherbrooke

    Investigators

    • Study Director: Michel Nguyen, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paul Farand, Investigator, Université de Sherbrooke
    ClinicalTrials.gov Identifier:
    NCT02316743
    Other Study ID Numbers:
    • Thyroid-001
    First Posted:
    Dec 15, 2014
    Last Update Posted:
    Dec 16, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic
    Hypothyroidism
    Systolic Murmurs

    Study Results

    No Results Posted as of Dec 16, 2014