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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01481402
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE November 25, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date July 16, 2019
Study Start Date  ICMJE July 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
left ventricle ejection fraction [ Time Frame: 3 months ]
The effect of liothyronine treatment in low dose in 3 months on LVEF.
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
LVEF [ Time Frame: 3 months ]
The effect of liothyronine treatment in low dose in 3 months on LVEF.
Change History Complete list of historical versions of study NCT01481402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Body composition [ Time Frame: 3 months ]
    The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
  • Body composition [ Time Frame: 3 months ]
    The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
Official Title  ICMJE Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Low T3 Syndrome
Intervention  ICMJE
  • Drug: Liothyronine
    Liothyronine 40 microgram per day
    Other Name: T3
  • Drug: Liothyronine
    3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
    Other Name: T3
Study Arms  ICMJE
  • Placebo Comparator: Placebo-liothyronine
    3 months of placebo followed by 3 months of Liothyronine treatment.
    Intervention: Drug: Liothyronine
  • Liothyronine-Placebo
    3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
    Intervention: Drug: Liothyronine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2011)
25
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481402
Other Study ID Numbers  ICMJE HerlevH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jens Faber, Herlev Hospital
Study Sponsor  ICMJE Jens Faber
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jens Faber, MDSci Herlev Hospital, Dept. of Endocrinology
PRS Account Herlev Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP