Developing Oral LT3 Therapy for Heart Failure - HFpEF
Heart Failure With Preserved Ejection Fraction · Low Triiodothyronine Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04111536 ↗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 Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats |
10; 12 | — |
| PRIMARY T3 Level |
7; 0 | — |
| SECONDARY Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max) |
9.53; 10.07 | — |
| SECONDARY Measure of Quality of Life |
0.1; 0.5 | — |
| SECONDARY Actigraphy |
224; 230 | — |
| SECONDARY NT-proBNP Levels |
51.4; 8.5 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Men and women aged ≥18 years; NYHA Class I, II or III heart failure or dyspnea on exertion without a clinically identifiable alternative cause; left ventricular ejection fraction greater than or equal to 40 percent; if taking antihypertensive medications, beta-blockers, SGLT2inhibitors, sacubitril/valsartan, or aldosterone antagonists, doses must be stable for at least 30 days. Elevated filling pressures as evidenced by at least 1 of the following:
- Mitral E/e' ratio > 14 (either lateral or septal)
- Mitral E/e' ratio > 8 (either lateral or septal), with low e' velocity (septal e' 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
- Probability of HFpEF>90%according to the HFpEF score,without a more likely apparent cause for symptoms as per Investigator assessment. TSH and free T4 level within the protocol specified reference range and total T3 level less than or equal to 0.94 ng/dL; if taking oral estrogen, dose must remain stable for duration of study participation.
Exclusion Criteria
Hypertrophic or restrictive cardiomyopathy or uncorrected severe primary valvular disease; inability to perform VO2max exercise testing; severe lung disease; treatment with oral steroids within past 6 months for an exacerbation of obstructive lung disease, or the use of daytime oxygen; serum creatinine > 3.0 mg/dL; history of cirrhosis; acute coronary syndrome or coronary artery intervention or ablation therapy within past 2 months; cardiac surgery or percutaneous valve or septal defect repair within the past 6 months; heart failure hospitalization within past month; 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; current or planned pregnancy within the timeframe of study participation; any medical condition that, in the opinion of the investigator, will interfere with safe completion of the study.
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Data sourced from ClinicalTrials.gov (NCT04111536). 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.