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

Not Applicable

Completed

• Conditions: Heart Failure; Low T3 Syndrome
• Interventions: Drug: Liothyronine

• Registration Number: NCT01481402
• Lead Sponsor: Jens Faber

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo-liothyronine	Liothyronine	3 months of placebo followed by 3 months of Liothyronine treatment.
Liothyronine-Placebo	Liothyronine	3 months of Liothyronine treatment followed by 3 months of Placebo treatment.

Primary Outcome Measures

Name	Time	Method
left ventricle ejection fraction	3 months	The effect of liothyronine treatment in low dose in 3 months on LVEF.

Secondary Outcome Measures

Name	Time	Method
NT-proBNP, EDV and ESV	3 months	The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.
GDF 8, SHBG, CK and PINP	3 months	The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure.
RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1	3 months	The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure.
Body composition	3 months	The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
Quality of Life, questionaire	3 months	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.
YKL-40, YNF-alpha, hsCRP and IL-6	3 months	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.

Trial Locations

Locations (1)

Herlev Hospital, Dept. of Endocrinology; 🇩🇰 Herlev, Denmark