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Completed

NCT Number: NCT01481402

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Endocrine System Diseases Euthyroid Sick Syndromes Heart Diseases Low T3 Syndrome Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Dept. of Endocrinology

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liothyronine

Drug

Liothyronine 40 microgram per day

Other names: T3

Primary outcomes

  1. left ventricle ejection fraction

    Time frame: 3 months

    The effect of liothyronine treatment in low dose in 3 months on LVEF.

Secondary outcomes

  1. Body composition

    Time frame: 3 months

    The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.

  2. Quality of Life, questionaire

    Time frame: 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.

  3. YKL-40, YNF-alpha, hsCRP and IL-6

    Time frame: 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.

  4. RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1

    Time frame: 3 months

    The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure.

  5. GDF 8, SHBG, CK and PINP

    Time frame: 3 months

    The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure.

  6. NT-proBNP, EDV and ESV

    Time frame: 3 months

    The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.

Sponsors and collaborators

Lead sponsor

Jens Faber

Other

Registry information

Official study title

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

Acronym: LIHFA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2011
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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