Status:
COMPLETED
Developing Oral LT3 Therapy for Heart Failure - HFrEF
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure With Reduced Ejection Fraction (HFrEF)
Low T3 Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 t...
Detailed Description
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 fr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04112316
Start Date
February 11 2020
End Date
October 31 2023
Last Update
December 24 2024
Active Locations (1)
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1
PennMedicine
Philadelphia, Pennsylvania, United States, 19104