Back to resultsLiothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF) (LIHFA)
Primary Purpose
Heart Failure, Low T3 Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Liothyronine
Liothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Liothyronine, Low T3 syndrome
Eligibility 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
Sites / Locations
- Herlev Hospital, Dept. of Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Other
Arm Label
Placebo-liothyronine
Liothyronine-Placebo
Arm Description
3 months of placebo followed by 3 months of Liothyronine treatment.
3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
Outcomes
Primary Outcome Measures
left ventricle ejection fraction
The effect of liothyronine treatment in low dose in 3 months on LVEF.
Secondary Outcome Measures
Body composition
The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
Quality of Life, questionaire
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
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
The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure.
GDF 8, SHBG, CK and PINP
The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure.
NT-proBNP, EDV and ESV
The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01481402
Brief Title
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
Acronym
LIHFA
Official Title
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Faber
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Low T3 Syndrome
Keywords
Heart failure, Liothyronine, Low T3 syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo-liothyronine
Arm Type
Placebo Comparator
Arm Description
3 months of placebo followed by 3 months of Liothyronine treatment.
Arm Title
Liothyronine-Placebo
Arm Type
Other
Arm Description
3 months of Liothyronine treatment followed by 3 months of Placebo treatment.
Intervention Type
Drug
Intervention Name(s)
Liothyronine
Other Intervention Name(s)
T3
Intervention Description
Liothyronine 40 microgram per day
Intervention Type
Drug
Intervention Name(s)
Liothyronine
Other Intervention Name(s)
T3
Intervention Description
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
Primary Outcome Measure Information:
Title
left ventricle ejection fraction
Description
The effect of liothyronine treatment in low dose in 3 months on LVEF.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body composition
Description
The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
Time Frame
3 months
Title
Quality of Life, questionaire
Description
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.
Time Frame
3 months
Title
YKL-40, YNF-alpha, hsCRP and IL-6
Description
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.
Time Frame
3 months
Title
RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1
Description
The effect of 3 months low dose liothyronine treatment on metabolic status in patients with heart failure.
Time Frame
3 months
Title
GDF 8, SHBG, CK and PINP
Description
The effect of 3 months low dose liothyronine treatment on the extrathyroidal thyroid effect in patients with heart failure.
Time Frame
3 months
Title
NT-proBNP, EDV and ESV
Description
The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Faber, MDSci
Organizational Affiliation
Herlev Hospital, Dept. of Endocrinology
Official's Role
Study Director
Facility Information:
Facility Name
Herlev Hospital, Dept. of Endocrinology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
We'll reach out to this number within 24 hrs