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

July 12, 2019 updated by: Jens Faber

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Herlev Hospital, Dept. of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Drug: Liothyronine
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
Other Names:
  • T3
Other: Liothyronine-Placebo
3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
Drug: Liothyronine
Liothyronine 40 microgram per day
Other Names:
  • T3
Drug: Liothyronine
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
Other Names:
  • T3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricle ejection fraction
Time Frame: 3 months
The effect of liothyronine treatment in low dose in 3 months on LVEF.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 months
The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
3 months
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 months
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.
3 months
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.
3 months
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Faber

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HerlevH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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