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

Information source: Herlev Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure; Low T3 Syndrome

Intervention: Liothyronine (Drug); Liothyronine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Jens Faber

Official(s) and/or principal investigator(s):
Jens Faber, MDSci, Study Director, Affiliation: Herlev Hospital, Dept. of Endocrinology

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: LVEF

Secondary outcome:

Body composition

Quality of Life

YKL-40, YNF-alpha, hsCRP and IL-6

RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1

GDF 8, SHBG, CK and PINP

NT-proBNP, EDV and ESV

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Herlev Hospital, Dept. of Endocrinology, Herlev 2730, Denmark
Additional Information

Starting date: July 2011
Last updated: February 25, 2014

Page last updated: August 23, 2015

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