Heart FailureLIHFANCT01481402
Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
A study testing Liothyronine in people with Heart Failure and Low T3 Syndrome, run by Jens Faber at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Low T3 Syndrome
- What is being tested?
- Liothyronine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Low T3 Syndrome
- Being tested
- Liothyronine
- Keywords
- Heart failure, Liothyronine, Low T3 syndrome
- Medical subject headings
- Heart Failure, Euthyroid Sick Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiothyronineDrug
Also called T3
Liothyronine 40 microgram per day
LiothyronineDrug
Also called T3
3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
| Study group | Role | What they receive |
|---|---|---|
| Placebo-liothyronine | Placebo comparator | 3 months of placebo followed by 3 months of Liothyronine treatment. Receives: Drug: Liothyronine |
| Liothyronine-Placebo | Other | 3 months of Liothyronine treatment followed by 3 months of Placebo treatment. Receives: Drug: Liothyronine |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricle ejection fraction
The effect of liothyronine treatment in low dose in 3 months on LVEF.
Measured: 3 months
Secondary outcomes (6)
Body composition
The effect of 3 months low dose liothyronine treatment on body composition in patients with heart failure.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
NT-proBNP, EDV and ESV
The effect of 3 months low dose liothyronine treatment on heart function in patients with heart failure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Faber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Faber, Herlev Hospital
- Investigators
- Jens Faber, MDSci, Study director, Herlev Hospital, Dept. of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481402
- Sponsor's protocol ID
- HerlevH
- Acronym
- LIHFA
- Status last verified
- Feb 2014
- First submitted
- 25 Nov 2011
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
- ClinicalTrials.gov ID
- NCT01481402
- Acronym / sponsor ID
- LIHFA / HerlevH
- Conditions
- Heart Failure, Low T3 Syndrome
- Keywords
- Heart failure, Liothyronine, Low T3 syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jens FaberUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-liothyronine | Placebo comparator | Drug: Liothyronine3 months of placebo followed by 3 months of Liothyronine treatment. |
| Liothyronine-Placebo | Other | Drug: Liothyronine3 months of Liothyronine treatment followed by 3 months of Placebo treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiothyronineAlso: T3Liothyronine 40 microgram per day | Drug | Placebo-liothyronine |
| LiothyronineAlso: T33 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral) | Drug | Liothyronine-Placebo |
Primary outcome
left ventricle ejection fraction
Time frame: 3 months
The effect of liothyronine treatment in low dose in 3 months on LVEF.
6 secondary outcomes
Body composition
Time frame: 3 months
Quality of Life, questionaire
Time frame: 3 months
YKL-40, YNF-alpha, hsCRP and IL-6
Time frame: 3 months
RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1
Time frame: 3 months
GDF 8, SHBG, CK and PINP
Time frame: 3 months
NT-proBNP, EDV and ESV
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Faber, MDSci study director
Herlev Hospital, Dept. of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liothyronine in people with Heart Failure and Low T3 Syndrome, run by Jens Faber at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricle ejection fraction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.