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 compositionQuality 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
|