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

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ClinicalTrials.gov Identifier: NCT01481402
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Failure Low T3 Syndrome Drug: Liothyronine Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
Study Start Date : July 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo-liothyronine
3 months of placebo followed by 3 months of Liothyronine treatment.
Drug: Liothyronine
Liothyronine 40 microgram per day
Other Name: T3
Liothyronine-Placebo
3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
Drug: Liothyronine
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
Other Name: T3



Primary Outcome Measures :
  1. LVEF [ Time Frame: 3 months ]
    The effect of liothyronine treatment in low dose in 3 months on LVEF.


Secondary Outcome Measures :
  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 [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481402


Locations
Denmark
Herlev Hospital, Dept. of Endocrinology
Herlev, Denmark, 2730
Sponsors and Collaborators
Jens Faber
Investigators
Study Director: Jens Faber, MDSci Herlev Hospital, Dept. of Endocrinology

Responsible Party: Jens Faber, professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01481402     History of Changes
Other Study ID Numbers: HerlevH
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Jens Faber, Herlev Hospital:
Heart failure
Liothyronine
Low T3 syndrome

Additional relevant MeSH terms:
Heart Failure
Euthyroid Sick Syndromes
Heart Diseases
Cardiovascular Diseases
Thyroid Diseases
Endocrine System Diseases