Effects of Levothyroxine Supplementation in Patients With... | NCT02316743

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

NCT02316743

Sponsor

Université de Sherbrooke

Status

Unknown status

Last Update Posted

Dec 16, 2014Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Systolic Heart Failure
Sub-clinical Hypothyroidism

Interventions

Levothyroxine supplementation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

Dec 10, 2014

First Posted Date

Dec 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levothyroxine	Experimental	Levothyroxine supplementation	Drug: Levothyroxine supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levothyroxine supplementation	Drug	T4 supplementation for heart failure patients with subclinical hypothyroidism.	Levothyroxine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance at the 6 minutes walk test		6 months

Secondary Outcomes

Measure	Description	Time Frame
Difference of the brain natriuretic peptide measurement		6 months
Difference of activin a measurement		6 months
Difference of myostatin measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michel Nguyen, MD	Contact	819-346-1110	70323	michel.nguyen@usherbrooke.ca

Overall Officials

Name	Affiliation	Role
Michel Nguyen, MD	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Sherbrooke	Recruiting	Sherbrooke	Quebec	J1H 5N4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D054143	Heart Failure, Systolic

Ancestor Terms

ID	Term
D006333	Heart Failure
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided