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

December 13, 2014 updated by: Paul Farand, Université de Sherbrooke

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine
Levothyroxine supplementation
Drug: Levothyroxine supplementation
T4 supplementation for heart failure patients with subclinical hypothyroidism.
Other Names:
  • T4 supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Performance at the 6 minutes walk test
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of the brain natriuretic peptide measurement
Time Frame: 6 months
6 months
Difference of activin a measurement
Time Frame: 6 months
6 months
Difference of myostatin measurement
Time Frame: 6 months
6 months
Increase in heart rate measurement
Time Frame: 6 months
Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months
6 months
Difference of systolic and diastolic function on transthoracic echocardiogram
Time Frame: 6 months
6 months
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)
Time Frame: 6 months
6 months
Normalisation of thyroid workup
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 13, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thyroid-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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