CompletedPhase 1/2

Developing Oral LT3 Therapy for Heart Failure - HFpEF

United States28 participantsStarted 2020-03-08

Plain-language summary

Investigation of the safety, feasibility, and preliminary efficacy of thyroid hormone therapy with Liothyronine (LT3) in individuals with heart failure with preserved ejection fraction (HFpEF) 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Mitral E/e' ratio \> 14 (either lateral or septal)
✓. Mitral E/e' ratio \> 8 (either lateral or septal), with low e' velocity (septal e'\<7 cm/sec or lateral e'\< 10 cm/sec), in addition to one of the following:
✓. Enlarged left atrium (LA volume index \>34 ml/m2)
✓. Chronic loop diuretic use for control of symptoms
✓. Elevated natriuretic peptides (BNP levels \>100 ng/L or NT-proBNP levels \>300 ng/L)
✓. Tricuspid regurgitation velocity \>2.8 m/s
✓. Elevated invasively-determined filling pressures previously (resting LVEDP \>16 mmHg or mean pulmonary capillary wedge pressure \[PCWP\] \>12 mmHg; or PCWP/LVEDP ≥25 mmHg with exercise)
✓. Acute heart failure decompensation with radiographic evidence of pulmonary venous congestion or alveolar edema, requiring IV diuretics within the past year

What they're measuring

Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats

Timeframe: continuous during intervention (14 days)

T3 Level

Timeframe: 8 weeks

Trial details

NCT IDNCT04111536

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Results submitted2024-08-27

View on ClinicalTrials.gov More Heart Failure With Preserved Ejection Fraction trials