An interventional study of N-of-1 trials and Enhanced usual care in Heart Failure, Beta-blocker and Older Adults, sponsored by Brigham and Women's Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
In this study we seek to understand whether N-of-1 trials using a crossover withdrawal/reversal design with 1-5 three-week periods can be used to identify the highest tolerated beta-blocker dose for patients with Heart Failure with Reduced Ejection Fraction (HFrEF). To achieve this objective we will conduct a 2-arm randomized controlled trial of 50 participants, comparing intervention(N-of-1 trials) to enhanced usual care.
For participants randomized to the intervention, we will use collect data via validated patient-reported outcomes and then display this data on a visualization tool. This tool was iteratively developed for N-of-1 trials with patient input - a comparison of how the patient felt on different doses of the same beta-blocker. If well-tolerated and the participant agrees to continue with dose escalation based on review of their data, the participant will take a higher dose for the next 3-week period; and the study team will again collect data on how they feel during this time. This approach of sharing end-of-period data with participants and subsequently escalating the dose (based on the participant's decision) for another 3-week period will continue until the guideline-directed target dose is reached or until the participant feels that their symptoms are limiting dose escalation. The N-of-1 intervention is purposefully structured to allow the participant to participate in 1-5 three-week periods (and as many dose combinations) as they wish until they are confident that they have reached their highest tolerated dose. This adaptive design for N-of-1 trials is intended to be patient-centered and patient-driven.
We will also conduct brief semi-structured interviews with intervention participants.
Participants randomized to enhanced usual care will not have access to patient-reported outcomes or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
Exclusion Criteria:
N-of-1 trials using a crossover withdrawal/reversal design will allow for 1-5 three-week periods as needed to identify the highest tolerated beta-blocker dose
Behavioral: N-of-1 trials
We will compare the intervention to an "enhanced usual care." Our study team will not provide guidance for dose titration (this will be at physician and patient discretion); and participants will not have access to PROs or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
Behavioral: Enhanced usual care
N-of-1 trials using a crossover withdrawal/reversal design will allow for 1-5 three-week periods as needed to identify the highest tolerated beta-blocker dose
We will compare the intervention to an "enhanced usual care." Our study team will not provide guidance for dose titration (this will be at physician and patient discretion); and participants will not have access to PROs or the data visualization tool. Since attention can affect outcomes, we will "enhance usual care" by conducting phone calls at the same frequency as the intervention group.
Beta-blocker dose at 4 months post-randomization
Our primary endpoint is the beta-blocker dose at 4 months post-randomization, expressed as a proportion of the guideline-recommended target dose
Time frame: 120 days
Proportion of participants taking ≥50% of target dose
The secondary outcome will be the proportion of participants taking at least ≥50% of target beta-blocker dose.
Time frame: 120 days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Brigham and Women's Hospital