CompletedPhase 1/2

Developing Oral LT3 Therapy for Heart Failure - HFrEF

United States28 participantsStarted 2020-02-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 \<94 ng/dL

Exclusion criteria

✕. 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

What they're measuring

Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment

Timeframe: continuous during intervention (14 days)

T3 Level

Timeframe: 8 weeks

Trial details

NCT IDNCT04112316

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Results submitted2024-08-27

View on ClinicalTrials.gov More Heart Failure With Reduced Ejection Fraction (HFrEF) trials