N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

50 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

50 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Brigham and Women's Hospital

Study start

Jul 31, 2026 Actual

Primary completion

Sep 5, 2027 Estimated

Study completion

Oct 5, 2027 Estimated

First posted

Mar 24, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.