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Clinical Trial NCT07489352 for Heart Failure, Beta-blocker, Older Adults is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure 50 Randomized Adaptive Design Crossover Design Dose Escalation

Not yet recruiting
Clinical Trial NCT07489352 is an interventional study for Heart Failure, Beta-blocker, Older Adults and is currently not yet recruiting. Enrollment is planned to begin on May 5, 2026 and continue until the study accrues 50 participants. Led by Brigham and Women's Hospital, this study is expected to complete by March 5, 2027. The latest data from ClinicalTrials.gov was last updated on March 24, 2026.
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...Show More
Official Title

N-of-1 Trials to Promote Patient-Centered Beta-Blocker Titration in Heart Failure With Reduced Ejection Fraction

Conditions
Heart FailureBeta-blockerOlder Adults
Other Study IDs
NCT ID Number
NCT07489352
Start Date (Actual)
2026-05-05
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-03-05
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Guideline-directed medical therapy
N-of-1 trials
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalN-of-1 Trials
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
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
Active ComparatorEnhanced 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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Maximum beta-blocker dose achieved
Our primary endpoint is the maximum beta-blocker dose achieved, in proportion to target dose.
120 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
120 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
60 Years
Eligible Sexes
All
  • 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)

  • Contraindication to beta-blocker including allergy
  • Treating physician disapproval of enrollment
  • Clinical instability
Brigham and Women's Hospital logoBrigham and Women's Hospital398 active studies to explore
  • National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
  • Weill Medical College of Cornell University logoWeill Medical College of Cornell University
Study Responsible Party
Julie Lauffenburger, Principal Investigator, Associate Professor, Brigham and Women's Hospital
Study Central Contact
Contact: Parag Goyal, MD, MSc, (646) 962-7571, [email protected]
Contact: Julie Lauffenburger, PharmD, PhD, [email protected]
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