Heart Failure Clinical Trial
Developing Oral LT3 Therapy for Heart Failure – HFrEF
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 triiothyronine (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). 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.
Men and women aged ≥18 years
NYHA Class I, II or III heart failure
EF≤40 percent within the past year
An implantable cardioverter-defibrillator (ICD)
Stable doses of neurohormonal blockade for 30 days
TSH and free T4 level within the laboratory reference range and total T3 level <94 ng/dL
Hypertrophic or restrictive cardiomyopathy
Uncorrected severe primary valvular disease
Arrhythmia that results in irregular heart rate
Inability to perform VO2max exercise testing
Severe lung disease, including treatment with oral steroids within past 6 months for exacerbation of obstructive lung disease or use of daytime supplemental oxygen
Serum creatinine > 3.0 mg/dL
History of cirrhosis
Heart failure hospitalization within past month
Acute coronary syndrome, coronary intervention or ablation therapy within past 2 months or cardiac surgery, percutaneous repair of a valve or septal defect repair within the past 6 months
Taking thyroid extract, LT4, LT3, amiodarone, or medication that affects the absorption or metabolism of thyroid hormone; gastrointestinal conditions that affect the absorption of thyroid hormone
If female, current or planned pregnancy within the timeframe of study participation
Any medical condition that in the opinion of the investigator, will interfere with the safe completion of the study.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.