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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Faber, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01481402
First received: November 25, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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 Intervention
Heart Failure
Low T3 Syndrome
Drug: Liothyronine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • LVEF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The effect of liothyronine treatment in low dose in 3 months on LVEF.


Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.

  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.


Enrollment: 21
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jens Faber, professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01481402     History of Changes
Other Study ID Numbers: HerlevH
Study First Received: November 25, 2011
Last Updated: February 25, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Heart Failure
Syndrome
Cardiovascular Diseases
Disease
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014