This seems like a very tentative effort in terms of rapamycin research; a very low dose (but taken every two days, then every day). I think most experienced rapamycin researchers would probably encourage them to up the dose and go less frequently, like was done in the Mannic 2014 study.
The thing I find interesting is using V02Max as the primary outcome measure. I’ve been wanting to do a VO2 Max test for the past few years, but they’ve all been closed or difficult to get into in my geographic location. But - its something we could measure easily (many universities and colleges have exercise physiology labs where the provide this type of test for about $50), so as Covid recedes, hopefully we can do this type of test and I encourage people moving to try rapamycin to do a pre and post test and report back here after the 6 month “post” test.
This will be a pilot, proof-of-concept study. Patients 60 years or older with invasively proven HFpEF or have definite HFpEF as determined by the 2 established scores and frailty (positive screen for computable phenotype), will be approached for enrollment. Subjects meeting screening criteria following written informed consent including hsCRP levels ≥2mg/L will undergo treatment with open label rapamycin. Efficacy outcomes will be measured at baseline and at 6 months. Safety will be assessed by remote video monitoring weekly for 1 month, then monthly for 5 months till the end of the study. We will also measure trough rapamycin levels (≤4ng/mL) twice-a-month for the first month and then monthly for 5 months.
We will start the dose at 0.5mg capsule every other day for 2 weeks. If participants tolerate this dose and trough blood levels are (≤4ng/mL), the dose of rapamycin will be increased to 0.5mg daily for the duration of the study. If necessary, dose can remain at 0.5 mg every other day, depending on the trough level. To avoid immunosuppression, we will target lower dose of rapamycin, maintain lower trough serum levels (≤4ng/mL).
Primary Outcome Measure: Change cardiopulmonary reserve capacity by improving peak VO2 with rapamycin [ Time Frame: 6 months ]
In this pilot, proof-of-concept study, we hypothesize that in older adults (≥60 years) with HFpEF who are frail with increased hsCRP (≥2mg/L), chronic rapamycin administration will change their cardiopulmonary reserve capacity by improving peak VO2.Primary safety objective is the safety of rapamycin.
Full Study Info: