Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with reduced ejection fraction (HFrEF) and low triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.
The overall goal is to determine the safety, feasibility, and preliminary efficacy of administering oral LT3 therapy in the study population of participants with Heart Failure with reduced ejection fraction (HFrEF). The study will consist of two treatment periods - each treatment period will be approximately 8 weeks in duration, with weekly titration of study drug for 4 weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to the other arm (placebo or drug). LT3 will be titrated to T3 levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
28
Liothyronine (L-triiodothyronine or LT3) in the 5 mcg tablet dose formulation. Minimum LT3 dose was 2.5 mcg three times daily and the maximum LT3 dose was 12.5 mcg three times daily.
A placebo tablet matching in appearance to LT3 tablets. Minimum placebo tablet dose was 1/2 tablet three times daily and the maximum placebo dose was 2 1/2 tablets three times daily.
PennMedicine
Philadelphia, Pennsylvania, United States
Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment
Number of participants with atrial fibrillation or ventricular tachycardia \>= 4 beats
Time frame: continuous during intervention (14 days)
T3 Level
Number of participants with T3 levels above upper limit of reference range
Time frame: 8 weeks
Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)
Change in peak rate of oxygen consumption during exercise between baseline and 8 weeks
Time frame: 8 weeks
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life
Change in KCCQ from baseline to 8 weeks, 0-100 scale, higher is better
Time frame: 8 weeks
Activity Measured Via Actigraphy
Remotely sensed minutes/day of cumulative light, moderate, or vigorous activity in minutes/day after 8 weeks of LT3 or placebo
Time frame: 8 weeks
Change in NT-proBNP Levels
Change in B-type natriuretic peptide levels, Pg/mL, from baseline to 8 weeks
Time frame: 8 weeks
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