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

NCT07489352 | Not Yet Recruiting

• 2 other identifiers: 2026P0004575P30AG064199-07
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study we seek to understand whether N-of-1 trials using a crossover withdrawal/reversal design with as many 2-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 beta-blockers. 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 2-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 2-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 as many 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.

Conditions

Heart Failure; Beta-blocker; Older Adults

Keywords

Guideline-directed medical therapy; N-of-1 trials

Outcome Measures

Primary Outcomes (1)

• Maximum beta-blocker dose achieved

  Our primary endpoint is the maximum beta-blocker dose achieved, in proportion to target dose.

  120 days

Secondary Outcomes (1)

• Proportion of participants taking >50% of target dose

  120 days

Study Arms (2)

N-of-1 Trials

EXPERIMENTAL

N-of-1 trials using a crossover withdrawal/reversal design will allow for as many 2-week periods as needed to identify the highest tolerated beta-blocker dose

Behavioral: N-of-1 trials

Enhanced usual care

ACTIVE COMPARATOR

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

Interventions

N-of-1 trials BEHAVIORAL

N-of-1 trials using a crossover withdrawal/reversal design will allow for as many 2-week periods as needed to identify the highest tolerated beta-blocker dose

N-of-1 Trials

Enhanced usual care BEHAVIORAL

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.

Enhanced usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥60 years
• Diagnosed with HFrEF (LVEF \<40%)
• Taking below 50% of guideline-based target β-blocker dose (guideline-based target doses: metoprolol 200mg daily; carvedilol 25mg BID; bisoprolol 10mg daily)

You may not qualify if:

• Contraindication to beta-blocker including allergy
• Treating physician disapproval of enrollment
• Clinical instability

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Weill Medical College of Cornell University: collaborator

MeSH Terms

Conditions

Heart Failure

Interventions

Single-Case Studies as Topic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Parag Goyal, MD, MSc

CONTACT

(646) 962-7571; pag9051@med.cornell.edu

Julie Lauffenburger, PharmD, PhD

CONTACT

jlauffenubrger@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): March 5, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03