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

This study is currently recruiting participants.

Verified November 2011 by Herlev Hospital

Sponsor:

Information provided by (Responsible Party):

Jens Faber, Herlev Hospital

ClinicalTrials.gov Identifier:

NCT01481402

First received: November 25, 2011

Last updated: November 28, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2011

Last Updated Date

November 28, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

LVEF [ Time Frame: 3 months ] [ Designated as safety issue: No ]

The effect of liothyronine treatment in low dose in 3 months on LVEF.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01481402 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jens Faber, MDSci

004538689016

jenfab01@heh.regionh.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01481402

Other Study ID Numbers ^ICMJE

HerlevH

Has Data Monitoring Committee

Yes

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

Information Provided By

Herlev Hospital

Verification Date

November 2011

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

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