HFrEF - Heart Failure With Reduced Ejection FractionPhase 4N-of-1 AppNCT07252310
Pilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App)
A Phase 4 study testing beta blockers and StudyU Application in people with HFrEF - Heart Failure With Reduced Ejection Fraction and Heart Failure, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HFrEF - Heart Failure With Reduced Ejection Fraction, Heart Failure, Heart Failure, Systolic
- What is being tested?
- beta blockers and StudyU Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to Aug 2027
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adults ≥ 65 years old
- A history of HFrEF per electronic medical record review/clinician impression that is defined as an EF <50% that is shown from any imaging modality
- Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment
- Access to a smartphone or device that can perform many of the same functions as a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications
Who cannot join
- Clinical instability (this N-of-trial is appropriate for stable conditions only)
- Decompensated HF
- Hospitalized in the past 30 days
- Medication changes or procedures in prior 14 days (to prevent confounding from other interventions) at PI discretion
- Do not have access to a smartphone or tablet
- Estimated life expectancy <6 months
Show all 11Show fewer
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Language barrier that will preclude informed consent and ability to comprehend 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 Principal Investigator 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
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Pilot Study of Acceptability and Feasibility of StudyU for N-of-1 Trials
This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker.
Read the detailed description
The overarching goal of this study is to determine feasibility of the StudyU app in N-of-1 trials. The study intervention is N-of-1 trials, facilitated by a mobile-based application, StudyU. The study team will utilize a single-arm sequential design N-of-1 study in which subjects who are not yet at the GDMT for beta blockers will test multiple doses of GDMT to understand the maximally tolerated dose using an N-of-1 trial format. This is similar to an approach used in a previous study, Pilot Deprescribing N-of-1 Trials for beta blockers in HFpEF (NCT04757584) but will test the addition of a mobile-based app to collect vital signs, monitor side effects, and monitor patient-reported outcomes.
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, Heart Failure, Heart Failure, Systolic, Heart Diseases
- Being tested
- beta blockers, StudyU Application
- Keywords
- HFrEF, App, N-of-1, GDMT, StudyU, Beta Blocker
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Diseases, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta blockersDrug
Subjects will remain on their current home dose of beta blocker (as prescribed by their treating physician prior to enrollment) during Period 1. In Period 2, the dose will be increased -either doubled or by 50%-to support progression toward the guideline-directed medical therapy (GDMT) target. may choose to continue on the tested dose and conclude the study, or request additional information before selecting their preferred dose. If both the participant and the study clinician agree that further evaluation is needed, a third period will be initiated. In this period, the dose may again be increased-by 50% or doubled relative to the Period 2 dose-if tolerated and agreed upon by the participant. If the new dose is well-tolerated and the participant agrees to continue with dose escalation after reviewing their data, the dose will be increased again-either doubled or increased by 50%-for the next period (Period 3). The study team will continue to collect data.
StudyU ApplicationDevice
StudyU is a novel mobile app developed for the design of and conduct of N-of-1 trials. StudyU consists of the StudyU Designer, a web platform and mobile app, accessible through the website https://designer.studyu.health; the StudyU App for smartphones, which can be downloaded from Apple and Google app stores, and the secure backend where data is stored. All components of StudyU were developed by Dr. Stefan Konigorski and his colleagues at Hasso-Plattner Institute (HPI) for Digital Engineering at the University of Potsdam. The StudyU platform allows investigators to easily operationalize their study processes in the StudyU designer. In the StudyU designer, investigators indicate at which frequency subjects will complete assessments. For this pilot trial, a WCM-specific instance of StudyU will be developed and hosted on the secure WCM server. Only the WCM study team will have access to the subject data from the StudyU App.
| Study group | Role | What they receive |
|---|---|---|
| GDMT (Beta Blockers) | Experimental | This study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive. Receives: Drug: beta blockers; Device: StudyU Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure Score
The Feasibility of Intervention (FIM) measure is a survey that evaluates an intervention's practicality. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher feasibility and lower indicating less feasibility. Total scores range from 4 to 20. A score of 4 indicates low feasibility and a score of 20 indicates strong feasibility.
Measured: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Intervention Appropriateness Measure Score
The Intervention Appropriateness Measure (IAM) is a survey that evaluates an intervention's suitability and compatibility. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher appropriateness and lower indicating less appropriateness. Total scores range from 4 to 20. A score of 4 indicates low appropriateness and a score of 20 indicates strong appropriateness.
Measured: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Acceptability of Intervention Measure Score
Acceptability of Intervention Measure (AIM) is a survey that evaluates how agreeable an intervention is to participants. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher acceptability and lower indicating less acceptability. Total scores range from 4 to 20. A score of 4 indicates low acceptability and a score of 20 indicates strong acceptability.
Measured: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Secondary outcomes (4)
Change in KCCQ-12 Score
The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) is a heart failure-specific health status survey. Questions are ranked on 5- to 7-point Likert scales, with higher scores indicating better health status and lower indicating worse health status. Total scores range from 0 to 100. A score of 0 indicates the worst health statues and a score of 100 indicates the best health status score. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose.
Measured: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS-29 Score
Patient-Reported Outcome Measurement Information System-29 (PROMIS) is a health-related quality of life survey, with questions from 7 domains: depression, anxiety, physical function, pain interference, pain intensity, sleep disturbance, and ability to engage in social roles and activities. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating better quality of life, and lower scores indicating poorer quality of life. Scores are reported for each domain. Total scores range for each domain except pain intensity is from 0 to 100. A score of 0 indicates no symptoms, whereas a 100 indicates extremely severe symptoms for each domain. For the pain intensity domain, there is a pain rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose.
Measured: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS CF-SF 6a Score
Patient-Reported Outcome Measurement Information System Cognitive Function - Short Form 6a (PROMIS CF-SF) Score is a health-related quality of life survey that focuses on the cognitive function domain. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating higher cognitive function, lower scores indicate lower cognitive function. Total scores range from 0 to 100. A score of 0 indicates worst possible cognitive function, whereas a 100 indicates best possible cognitive function. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose.
Measured: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS Sexual Function Score
Patient-Reported Outcome Measurement Information System (PROMIS) Sexual Function Score is a health-related quality of life survey that focuses on the sexual function domain. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating higher sexual function, lower scores indicate lower sexual function. Total scores range from 0 to 100. A score of 0 indicates no sexual interest/function/satisfaction whereas a 100 indicates high sexual interest/function/satisfaction. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose.
Measured: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start10 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HFrEF - Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag Goyal, MD, MSc, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252310
- Sponsor's protocol ID
- 25-08029225
- Acronym
- N-of-1 App
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goyal P, Safford MM, Hilmer SN, Steinman MA, Matlock DD, Maurer MS, Lachs MS, Kronish IM. N-of-1 trials to facilitate evidence-based deprescribing: Rationale and case study. Br J Clin Pharmacol. 2022 Oct;88(10):4460-4473. doi: 10.1111/bcp.15442. Epub 2022 Jul 13.
PubMed 35705532Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499Verhestraeten C, Heggermont WA, Maris M. Clinical inertia in the treatment of heart failure: a major issue to tackle. Heart Fail Rev. 2021 Nov;26(6):1359-1370. doi: 10.1007/s10741-020-09979-z.
PubMed 32474794Rao VN, Greene SJ. Breaking Clinical Inertia in Heart Failure Management. Jt Comm J Qual Patient Saf. 2022 Jan;48(1):3-4. doi: 10.1016/j.jcjq.2021.11.002. Epub 2021 Nov 11. No abstract available.
PubMed 34840128
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Acceptability and Feasibility of StudyU for N-of-1 Trials
- ClinicalTrials.gov ID
- NCT07252310
- Acronym / sponsor ID
- N-of-1 App / 25-08029225
- Conditions
- HFrEF - Heart Failure With Reduced Ejection Fraction, Heart Failure, Heart Failure, Systolic, Heart Diseases
- Keywords
- HFrEF, App, N-of-1, GDMT, StudyU, Beta Blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Nov 2025 (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.
This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker.
Detailed description
The overarching goal of this study is to determine feasibility of the StudyU app in N-of-1 trials. The study intervention is N-of-1 trials, facilitated by a mobile-based application, StudyU. The study team will utilize a single-arm sequential design N-of-1 study in which subjects who are not yet at the GDMT for beta blockers will test multiple doses of GDMT to understand the maximally tolerated dose using an N-of-1 trial format. This is similar to an approach used in a previous study, Pilot Deprescribing N-of-1 Trials for beta blockers in HFpEF (NCT04757584) but will test the addition of a mobile-based app to collect vital signs, monitor side effects, and monitor patient-reported outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDMT (Beta Blockers) | Experimental | Drug: beta blockers, Device: StudyU ApplicationThis study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 65 years old
- A history of HFrEF per electronic medical record review/clinician impression that is defined as an EF <50% that is shown from any imaging modality
- Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment
- Access to a smartphone or device that can perform many of the same functions as a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications
Key exclusion criteria (11 listed)
- Clinical instability (this N-of-trial is appropriate for stable conditions only)
- Do not have access to a smartphone or tablet
- Estimated life expectancy <6 months
- Moderate-severe dementia or psychiatric disorder precluding informed consent
- Language barrier that will preclude informed consent and ability to comprehend 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 |
|---|---|---|
| beta blockersSubjects will remain on their current home dose of beta blocker (as prescribed by their treating physician prior to enrollment) during Period 1. In Period 2, the dose will be increased -either doubled or by 50%-to support progression toward the guideline-directed medical therapy (GDMT) target. may choose to continue on the tested dose and conclude the study, or request additional information before selecting their preferred dose. If both the participant and the study clinician agree that further evaluation is needed, a third period will be initiated. In this period, the dose may again be increased-by 50% or doubled relative to the Period 2 dose-if tolerated and agreed upon by the participant. If the new dose is well-tolerated and the participant agrees to continue with dose escalation after reviewing their data, the dose will be increased again-either doubled or increased by 50%-for the next period (Period 3). The study team will continue to collect data. | Drug | GDMT (Beta Blockers) |
| StudyU ApplicationStudyU is a novel mobile app developed for the design of and conduct of N-of-1 trials. StudyU consists of the StudyU Designer, a web platform and mobile app, accessible through the website https://designer.studyu.health; the StudyU App for smartphones, which can be downloaded from Apple and Google app stores, and the secure backend where data is stored. All components of StudyU were developed by Dr. Stefan Konigorski and his colleagues at Hasso-Plattner Institute (HPI) for Digital Engineering at the University of Potsdam. The StudyU platform allows investigators to easily operationalize their study processes in the StudyU designer. In the StudyU designer, investigators indicate at which frequency subjects will complete assessments. For this pilot trial, a WCM-specific instance of StudyU will be developed and hosted on the secure WCM server. Only the WCM study team will have access to the subject data from the StudyU App. | Device | GDMT (Beta Blockers) |
Primary outcome
Feasibility of Intervention Measure Score
Time frame: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
The Feasibility of Intervention (FIM) measure is a survey that evaluates an intervention's practicality. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher feasibility and lower indicating less feasibility. Total scores range from 4 to 20. A score of 4 indicates low feasibility and a score of 20 indicates strong feasibility.
Intervention Appropriateness Measure Score
Time frame: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
The Intervention Appropriateness Measure (IAM) is a survey that evaluates an intervention's suitability and compatibility. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher appropriateness and lower indicating less appropriateness. Total scores range from 4 to 20. A score of 4 indicates low appropriateness and a score of 20 indicates strong appropriateness.
Acceptability of Intervention Measure Score
Time frame: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Acceptability of Intervention Measure (AIM) is a survey that evaluates how agreeable an intervention is to participants. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher acceptability and lower indicating less acceptability. Total scores range from 4 to 20. A score of 4 indicates low acceptability and a score of 20 indicates strong acceptability.
4 secondary outcomes
Change in KCCQ-12 Score
Time frame: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS-29 Score
Time frame: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS CF-SF 6a Score
Time frame: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
Change in PROMIS Sexual Function Score
Time frame: Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).
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 19 Feb 2026.
- Background: PubMed 35705532Goyal P, Safford MM, Hilmer SN, Steinman MA, Matlock DD, Maurer MS, Lachs MS, Kronish IM. N-of-1 trials to facilitate evidence-based deprescribing: Rationale and case study. Br J Clin Pharmacol. 2022 Oct;88(10):4460-4473. doi: 10.1111/bcp.15442. Epub 2022 Jul 13.
- Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Background: PubMed 35363499Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Background: PubMed 32474794Verhestraeten C, Heggermont WA, Maris M. Clinical inertia in the treatment of heart failure: a major issue to tackle. Heart Fail Rev. 2021 Nov;26(6):1359-1370. doi: 10.1007/s10741-020-09979-z.
- Background: PubMed 34840128Rao VN, Greene SJ. Breaking Clinical Inertia in Heart Failure Management. Jt Comm J Qual Patient Saf. 2022 Jan;48(1):3-4. doi: 10.1016/j.jcjq.2021.11.002. Epub 2021 Nov 11. No abstract available.
- Individual participant dataSharing planned: No
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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.
Parag Goyal, MD, MSc principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing beta blockers and StudyU Application in people with HFrEF - Heart Failure With Reduced Ejection Fraction and Heart Failure, run by Weill Medical College of Cornell University 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 4 inclusion and 11 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 19 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of Intervention Measure Score (time frame: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252310, which also lists 5 linked publications.
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 19 Feb 2026.