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

Heart Failure Clinical Trial

— LIHFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481402
• Other study ID #: HerlevH
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Euthyroid Sick Syndromes
• Heart Failure
• Low T3 Syndrome

Intervention

Drug:
• Liothyronine
Liothyronine 40 microgram per day
• Liothyronine
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)

Locations

Country	Name	City	State
Denmark	Herlev Hospital, Dept. of Endocrinology	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Jens Faber

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricle ejection fraction	The effect of liothyronine treatment in low dose in 3 months on LVEF.	3 months
Secondary	Body composition	The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	NT-proBNP, EDV and ESV	The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.	3 months