Heart FailureNCT07489352
N-of-1 Trial to Promote Beta-Blocker Titration in Heart Failure
A study testing N-of-1 trials in people with Heart Failure and Beta-blocker, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Beta-blocker, Older Adults
- What is being tested?
- N-of-1 trials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 5 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New York Presbyterian Hospital/Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: N-of-1 Trials to Promote Patient-Centered Beta-Blocker Titration in Heart Failure With Reduced Ejection Fraction
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.
Read more
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
- Being tested
- N-of-1 trials, Enhanced usual care
- Keywords
- Guideline-directed medical therapy, N-of-1 trials
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-of-1 trialsBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| N-of-1 Trials | Experimental | 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 Receives: 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. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120 days
Secondary outcomes (1)
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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start31 Jul 2026
- Primary completion5 Mar 2027 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489352
- Sponsor's protocol ID
- 2026P000457
- Other IDs
- 5P30AG064199-07
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-of-1 Trials to Promote Patient-Centered Beta-Blocker Titration in Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT07489352
- Acronym / sponsor ID
- 2026P000457
- Conditions
- Heart Failure, Beta-blocker, Older Adults
- Keywords
- Guideline-directed medical therapy, N-of-1 trials
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Weill Medical College of Cornell University
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-of-1 Trials | Experimental | Behavioral: N-of-1 trialsN-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 careWe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-of-1 trialsN-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 | Behavioural | N-of-1 Trials |
| Enhanced usual careWe 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. | Behavioural | Enhanced usual care |
Primary outcome
Beta-blocker dose at 4 months post-randomization
Time frame: 120 days
Our primary endpoint is the beta-blocker dose at 4 months post-randomization, expressed as a proportion of the guideline-recommended target dose
1 secondary outcome
Proportion of participants taking ≥50% of target dose
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-of-1 trials in people with Heart Failure and Beta-blocker, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-blocker dose at 4 months post-randomization (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.