Developing Oral LT3 Therapy for Heart Failure - HFpEF
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Low Triiodothyronine Syndrome
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Participant, Investigators and Care Providers are blinded to LT3 vs. Placebo and T3 results. There will be 1 unblinded physician in the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 preserved ejection fraction (HFpEF). Each treatment period will be approximately 8 weeks in duration, with weekly titra...
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 preserved ejection fraction (HFpEF). Each treatment period will be approximately 8 weeks in duration, with weekly titration of study drug for 4 weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to the other arm (placebo or drug). LT3 will be titrated to T3 levels.
Tracking Information
- NCT #
- NCT04111536
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Anne R Cappola, MD,ScM University of Pennsylvania
Get Well Soon