Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)

Study Overview
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Brief Summary
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Purpose: The purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.

Detailed Description
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The patients are examined 3 times. At baseline, after 3 months and after 6 months.After the examination is performed, they begin the study medication while admitted at Dept. of Cardiology, Herlev Hospital, for cardiac monitoring.

Official Title
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Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status

Conditions
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Heart Failure, Low T3 Syndrome

Intervention / Treatment
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* Drug: Liothyronine
* Drug: Liothyronine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable, chronic systolic heart failure T3 ≤1.4 nmol/l in two blood samples, TSH is to be normal LVEF ≤ 45 % on prior echocardiography Exclusion Criteria: Established thyroid illness Atrial fibrillation/flutter More than 20% ventricular extrasystoles Severe chronic obstructive lung disorder Pregnancy. Pregnancy testing will be done for fertile women Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo-liothyronine<br>3 months of placebo followed by 3 months of Liothyronine treatment. | Drug: Liothyronine<br>* Liothyronine 40 microgram per day<br>* Other names: T3;|
| Other: Liothyronine-Placebo<br>3 months of Liothyronine treatment followed by 3 months of Placebo treatment. | Drug: Liothyronine<br>* 3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)<br>* Other names: T3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricle ejection fraction | The effect of liothyronine treatment in low dose in 3 months on LVEF. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure. | 3 months | 
| Quality of Life, questionaire | The effect of 3 months low dose liothyronine treatment on quality of life, assessed by SF-36 and Minnesota Living with Heart Failure questionnaires in patients with heart failure. | 3 months | 
| YKL-40, YNF-alpha, hsCRP and IL-6 | The effect of 3 months low dose liothyronine treatment on low grade inflammation assessed by measurement of pro-inflammatory markers in patients with heart failure. | 3 months | 
| RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1 | The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure. | 3 months | 
| GDF 8, SHBG, CK and PINP | The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure. | 3 months | 
| NT-proBNP, EDV and ESV | The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Liothyronine, Low T3 syndrome