N-of-1 Trials to Promote Patient-Centered Beta-Blocker Titration in Heart Failure With Reduced Ejection Fraction
| Registry | NCT07489352 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 50 (Estimated) |
| Sponsor | Brigham and Women's Hospital (Other); collaborators: National Institute on Aging (NIA), Weill Medical College of Cornell University |
| Conditions | Heart Failure, Beta-blocker, Older Adults |
| Interventions | N-of-1 trials, Enhanced usual care (Behavioral) |
| Dates | start 2026-07-31, primary completion 2027-03-05 (estimated), completion 2027-03-05 (estimated), first posted 2026-03-24, last updated 2026-09-21 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| N-of-1 Trials | Experimental | Behavioral: N-of-1 trials | 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 |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual care | 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. |
Sex: All, ages: 50 Years to any
Inclusion Criteria: * Adults aged ≥50 years * Diagnosed with HFrEF (LVEF <40%) * Taking below 50% of guideline-based target β-blocker dose (guideline-based target doses: metoprolol succinate 200 mg daily; metoprolol tartrate 200 mg daily; carvedilol 50 mg daily (100 mg daily for participants >85 kg); bisoprolol 10 mg daily) Exclusion Criteria: * Clinical instability, including decompensated HF, hospitalization in the past 30 days, or medication changes/procedures in the prior 14 days at PI discretion * Estimated life expectancy <6 months * Moderate-severe dementia or psychiatric disorder precluding informed consent * Language barrier precluding informed consent or comprehension of study procedures * History of noncompliance or inability to complete study procedures * Enrollment in a clinical trial not approved for co-enrollment * Any condition that, in the PI's or treating physician's opinion, makes the patient unsuitable for study participation
| Facility | City | Country | Status |
|---|---|---|---|
| New York Presbyterian Hospital/Weill Medical College of Cornell University | New York, New York | United States |
NIH grants: P30AG064199