Developing Oral LT3 Therapy for Heart Failure - HFrEF

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure With Reduced Ejection Fraction (HFrEF), Low T3 Syndrome

In brief

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.

Key facts

Study ID

NCT04112316

Run by

University of Pennsylvania

People needed

28

Starts

2020-02-11

Expected to finish

2023-10-31

Last updated by the study team

2024-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• LVAD use
• 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.

Where it is running

• PennMedicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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