Systolic Heart FailurePhase 4NCT02316743
Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
A Phase 4 study testing Levothyroxine supplementation in people with Systolic Heart Failure and Sub-clinical Hypothyroidism, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure, Sub-clinical Hypothyroidism
- What is being tested?
- Levothyroxine supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Etienne L. Couture, MD, 819-346-1110 ext. 74326, etienne.couture@usherbroke.ca
Etienne L. Couture, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Levothyroxine supplementation
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine supplementationDrug
Also called T4 supplementation
T4 supplementation for heart failure patients with subclinical hypothyroidism.
| Study group | Role | What they receive |
|---|---|---|
| Levothyroxine | Experimental | Levothyroxine supplementation Receives: Drug: Levothyroxine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance at the 6 minutes walk test
Measured: 6 months
Secondary outcomes (7)
Difference of the brain natriuretic peptide measurement
Measured: 6 months
Difference of activin a measurement
Measured: 6 months
Difference of myostatin measurement
Measured: 6 months
Increase in heart rate measurement
Absence / Presence of tachycardia (heart rate > 100 beat per minute) at baseline and 6 months
Measured: 6 months
Difference of systolic and diastolic function on transthoracic echocardiogram
Measured: 6 months
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)
Measured: 6 months
Normalisation of thyroid workup
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Farand, Université de Sherbrooke
- Investigators
- Michel Nguyen, MD, Study director, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316743
- Sponsor's protocol ID
- Thyroid-001
- Status last verified
- Dec 2014
- First submitted
- 10 May 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT02316743
- Acronym / sponsor ID
- Thyroid-001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levothyroxine | Experimental | Drug: Levothyroxine supplementationLevothyroxine supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxine supplementationAlso: T4 supplementationT4 supplementation for heart failure patients with subclinical hypothyroidism. | Drug | Levothyroxine |
Primary outcome
Performance at the 6 minutes walk test
Time frame: 6 months
7 secondary outcomes
Difference of the brain natriuretic peptide measurement
Time frame: 6 months
Difference of activin a measurement
Time frame: 6 months
Difference of myostatin measurement
Time frame: 6 months
Increase in heart rate measurement
Time frame: 6 months
Difference of systolic and diastolic function on transthoracic echocardiogram
Time frame: 6 months
Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)
Time frame: 6 months
Normalisation of thyroid workup
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Nguyen, MD study director
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levothyroxine supplementation in people with Systolic Heart Failure and Sub-clinical Hypothyroidism, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Nguyen, MD (819-346-1110 ext. 70323, michel.nguyen@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance at the 6 minutes walk test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.