Heart Failure Clinical Trial
Official title:
A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
Investigators will determine whether N-of-1 trials, as a pragmatic, patient-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased subject confidence regarding the decision to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).
This is an unblinded NIH Stage I of Behavioral Intervention Development trial, using serial multiple-period single patient crossover design. Investigators will enroll 20 participants, conducting an N-of-1 trial in each of them. The intervention is a two-arm crossover withdrawal/reversal design (On [A] vs. Off [B]) with up to 6 periods, each period lasting up to 6 weeks. The sequence of treatment will be randomized to either ABAB or BABA. Each participant will have the option to participate in additional periods if they wish to gather more data. The intervention drug will be beta-blockers, previously prescribed to the subjects by their physician. The investigators have developed a titration algorithm, where the participant's dose of beta-blocker will be decreased by 50% every week prior to their Off [B] period. Similarly, investigators will increase participant's beta-blocker dose by 50% every week prior to their On [A] period. ;
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