Sub-clinical Hypothyroidism, Systolic Heart Failure
Conditions
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.
Interventions
DRUGLevothyroxine supplementation
T4 supplementation for heart failure patients with subclinical hypothyroidism.
Sponsors
Université de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance at the 6 minutes walk test | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of activin a measurement | 6 months | — |
| Difference of myostatin measurement | 6 months | — |
| Increase in heart rate measurement | 6 months | Absence / Presence of tachycardia (heart rate \> 100 beat per minute) at baseline and 6 months |
| Difference of the brain natriuretic peptide measurement | 6 months | — |
| Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization) | 6 months | — |
| Normalisation of thyroid workup | 6 months | — |
| Difference of systolic and diastolic function on transthoracic echocardiogram | 6 months | — |
Countries
Canada
Contacts
Primary ContactMichel Nguyen, MD
Outcome results
None listed