Phase 2
N=28
Developing Oral LT3 Therapy for Heart Failure - HFrEF
Heart Failure With Reduced Ejection Fraction (HFrEF) · Low T3 Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04112316 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment — 11; 19 Number of participants with events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liothyronine (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment |
11; 19 | — |
| PRIMARY T3 Level |
4; 0 | — |
| SECONDARY Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max) |
11.18; 10.78 | — |
| SECONDARY Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life |
0.6; -0.6 | — |
| SECONDARY Activity Measured Via Actigraphy |
241; 265 | — |
| SECONDARY Change in NT-proBNP Levels |
66.1; 98.7 | — |
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 triiodothyronine (T3) syndrome by conducting a randomized, double-blind, placebo-controlled cross-over study with a two-week washout period between treatments.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04112316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.