Clincosm LogoSign in Get a demo

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

Sponsor
Jens Faber (Other)
Overall Status
Completed
CT.gov ID
NCT01481402
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
31.1
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2011
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

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 Names:
  • T3

    		•
    Other: 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 Names:
  • T3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. left ventricle ejection fraction [3 months]

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

    Secondary Outcome Measures

    1. Body composition [3 months]

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

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. NT-proBNP, EDV and ESV [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herlev Hospital, Dept. of Endocrinology Herlev Denmark 2730

    Sponsors and Collaborators

    • Jens Faber

    Investigators

    • Study Director: Jens Faber, MDSci, Herlev Hospital, Dept. of Endocrinology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jens Faber, professor, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT01481402
    Other Study ID Numbers:
    • HerlevH
    First Posted:
    Nov 29, 2011
    Last Update Posted:
    Jul 16, 2019
    Last Verified:
    Feb 1, 2014
    Keywords provided by Jens Faber, professor, Herlev Hospital
    Heart failure
    Liothyronine
    Low T3 syndrome
    Additional relevant MeSH terms:
    Heart Failure
    Euthyroid Sick Syndromes

    Study Results

    No Results Posted as of Jul 16, 2019