Restoration of Chronotropic Competence in Heart Failure Patients with Normal Ejection Fraction (RESET)
Status: Currently enrolling patients
RESET is a pioneering effort that is exploring a device-based therapy solution for a population of heart failure (HF) patients with a preserved or normal EF, who currently have limited treatment options.
RESET is an ongoing trial and has not yet published results.
- Patients are stratified into two groups according to βB usage.
- Patients are evaluated for implant eligibility.
- Patients meeting screening criteria will be implanted.
- Therapy evaluated for each patient in a randomized order paired fashion at 1 month visits A & B.
- Pacing therapy will be evaluated again at 6 months.
- Patient clinical status and device will be assessed at 12 months.
Eligible study participants included both male and female patients, 18 years or older, that are NYHA Class II-III with an (EF) > 50%, and exhibit chronotropic incompetence.
Some of the exclusion criteria were:
- AFib or flutter 90 days prior to enrollment
- Primary pulmonary disease
- HCM or infiltrative cardiomyopathy
- Experienced unstable agina, MI, or undergone CABG or PTCA 60 days prior to enrollment
- Moderate or greater valve disease, repair or replacement
- Condition preventing exercise testing
Approximately 30 Centers in the U.S.
76 patients will be implanted
- 38 patients on βBs & 38 patients not on βBs
- To evaluate the effect of rate-adaptive pacing (RAP) therapy on functional capacity in patients with HF and a preserved EF
- Primary endpoint: peak oxygen uptake (pVO2)
- Secondary endpoint: quality of life (QoL)
- RESET is the first multicenter device based therapy trial undertaken in patients with HF and a preserved EF aimed at improving exertional tolerance and QoL