Heart FailurePhase 4PRE-INFORMEDNCT05585125
A Preliminary Study for INFORMED
A Phase 4 study testing Beta blocker in people with Heart Failure and Heart Failure, Diastolic, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Beta blocker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to Nov 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
- Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
- Taking beta-blocker
Who cannot join
- Alternate cause(s) of HFpEF Syndrome:
- Severe aortic stenosis
- Moderate-severe mitral stenosis
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
Show all 29Show fewer
- Other compelling indication(s) for beta-blocker
- Prior EF < 50%
- Hypertrophic cardiomyopathy
- Angina
- Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years
- History of ventricular tachycardia/arrhythmia
- Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
- Heart rate >100 bpm within the prior 3 months
- Atrial arrhythmia with ventricular rate >90 per minute in the prior 3 months
- Systolic blood pressure readings >160 mmHg within the prior 3 months, unless classified as white coat hypertension/effect (and home blood pressures below 140 mmHg)
- Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Decompensated heart failure
- Hospitalization in the past 30 days
- Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion
- Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion
- Clinical instability from other medical issues
- 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
- Non-compliance or inability to complete study procedures
- Enrollment in a clinical trial not approved for co-enrollment
- Any condition that, in the 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.
Parag Goyal, MD, MSc contact
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Srikar Savaram, BS, 646-962-7919, srs4011@med.cornel.edu
Parag Goyal, MD, MSc
About this study
Official title: A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).
Read the detailed description
This is an unblinded NIH Stage I of Behavioral Intervention Development trial, using serial multiple-period single participant crossover design. Investigators will enroll 20 participants, conducting an N-of-1 trial in each. The intervention is a two-arm crossover withdrawal/reversal design (On [A] vs. Off [B]) with up to 6 periods, each period lasting up to 6 weeks. The sequence of treatment will be randomized to either ABAB or BABA. Each participant will have the option to participate in additional (no more than 6) periods if they wish to gather more data. The intervention drug will be beta-blockers, previously prescribed to the participants by their physician. The investigators have developed a titration algorithm, where during the On period (A), participants will be on their baseline beta-blocker dose (or the highest dose they can safely tolerate). During the Off period (B), their beta-blockers will be down-titrated and subsequently discontinued (or at the lowest dose they can safely tolerate); we will decrease the dose of the beta-blocker by 50% every week regardless of which beta-blocker they are on. When returning to On, from Off, we will up-titrate by 50% until reaching their home dose (or the highest dose they can safely tolerate).
- Conditions
- Heart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Cardiac Failure, Heart Diseases
- Being tested
- Beta blocker
- Keywords
- Propranolol, Metoprolol, Atenolol, Sotalol, Nadolol, Acebutolol, Carvedilol, Nebivolol, Bisoprolol, Labetalol, Pindolol, Betaxolol, Penbutolol, Adrenergic beta-Antagonists, Adrenergic Antagonists, Adrenergic Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Anti-Arrhythmia Agents
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta blockerDrug
Also called ABAB
The intervention is a two-arm crossover withdrawal/reversal design (On [A] vs Off [B]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose).
Participants will be randomized into either ABAB or BABA sequences.
Other names:
acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol
Beta blockerDrug
Also called BABA
The intervention is a two-arm crossover withdrawal/reversal design (On [A] vs Off [B]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose).
Participants will be randomized into either ABAB or BABA sequences.
Other names:
acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol
| Study group | Role | What they receive |
|---|---|---|
| Beta-Blocker ABAB Sequence | Active comparator | This arm will follow an ABAB sequence: ON beta-blockers (A) and OFF beta-blockers (B). Participants start with their home beta-blocker dose in Period 1 (A), and then switch to Period 2 (B), where the dose is slowly reduced until they are off their beta-blocker (or the lowest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information to make a preference. These extra phases follow the same ON-OFF pattern (ABABAB), meaning if the participant chooses to continue into Period 3 (A), the study team will restart the participant's beta-blocker, and slowly up-titrate until they reach their home dose, or their highest tolerable dose. This continues until the participant has enough information to clarify their preference about their beta-blocker, with a limit of 6 periods. Receives: Drug: Beta blocker |
| Beta-Blocker BABA Sequence | Active comparator | This arm will follow a BABA sequence: OFF beta-blockers (B) and ON beta-blockers (A). Participants start Period 1 (B) by slowly reducing the participant's beta-blocker home dose by 50% each week until they are off (or the lowest tolerable dose), then switch to Period 2 (A), where they restart their beta-blocker and slowly up-titrate until they reach their home dose (or the highest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information. The extra phases follow the same OFF-ON pattern (BABABA), meaning if they choose to continue into Period 3 (B), the participant will slowly reduce their beta-blocker until they are off (or the lowest tolerable dose). This continues until the participant has enough information to clarify their preference about their beta-blocker, with a max of 6 periods. Receives: Drug: Beta blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews
Qualitative interviews will be conducted to assess the change in confidence through their experience participating in N-of-1 trials. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.
Measured: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.
Change in participant decision-confidence, as measured by the Decisional Conflict Scale (DCS)
Measures participant perceptions of uncertainty in decision-making, factors contributing to uncertainty, and effective decision-making. A set of 16 questions with responses ranging from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 and 100. Lower scores indicate feeling informed and low decisional conflict whereas higher scores indicate feelings of uncertainty and high decisional conflict.
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Secondary outcomes (7)
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials in participants with Heart Failure with Preserved Ejection Fraction, as measured by qualitative interviews.
Qualitative interviews will be conducted to assess the feasibility and acceptability of participant-facing materials and themes related to N-of-1 trials, and their experience participating in them, at each of the following time points. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.
Measured: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.
Change in participants feeling informed through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing participant's sense of knowing the options available to them and their benefits. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely informed) and 100 (feels extremely uninformed).
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants feeling uncertainty through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing how sure participants feel about making a given decision. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely certain about best choice) and 100 (feels extremely uncertain about best choice).
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants feeling supported through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 3 items within the Decisional Conflict Scale assessing if participant's feel supported or pressured by others when making a given decision. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (feels extremely supported in decision making) and 100 (feels extremely unsupported in decision making).
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants decision effectiveness through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
A set of 4 items within the Decisional Conflict Scale assessing if participants feel satisfied and informed in their decision making. Answers range from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 (good decision) and 100 (bad decision).
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in shared decision making through an N-of-1 protocol, as measured by the 9-item Shared Decision-Making Questionnaire
Measures participants feeling of inclusion during the decision-making process of their treatment options. The 9-item questionnaire asks participants to respond to statements with answers to the questions ranging from "completely disagree" to "completely agree". Responses range from (0) = "completely disagree" to (5) = "completely agree" and are scored on a six-point Likert scale. Scores are summed together to produce an overall score between 0 (low involvement and 45 (high involvement).
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participant activation through an N-of-1 protocol, as assessed by the Patient Activation Measure (PAM)
Assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. Participants respond to a set of statements with answers ranging from "disagree strongly," "disagree," "agree," "strongly agree," and "not applicable." The responses are quantified to produce a score ranging from 0 to 100, and respondents fall into one of four levels of participant activation: Disengaged \& Overwhelmed, Becoming Aware but still Struggling, Taking Action \& Gaining Control, and Maintaining Behaviors \& Pushing Further. A score of 0 (Disengaged \& Overwhelmed) indicates low participant activation, participant is passive with low healthcare knowledge and adherence. A score of 100 (Maintaining Behaviors \& Pushing Further) indicates high participant activation, with active maintenance of a healthy lifestyle.
Measured: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start7 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionNov 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Parag Goyal, MD, MSc, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585125
- Sponsor's protocol ID
- 23-03025862 frmrly 22-08025181
- Other IDs
- 5K76AG064428-03, formerly 22-08025181
- Acronym
- PRE-INFORMED
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization
- ClinicalTrials.gov ID
- NCT05585125
- Acronym / sponsor ID
- PRE-INFORMED / 23-03025862 frmrly 22-08025181
- Conditions
- Heart Failure, Heart Failure, Diastolic, Heart Failure With Preserved Ejection Fraction, Cardiac Failure, Heart Diseases
- Keywords
- Propranolol, Metoprolol, Atenolol, Sotalol, Nadolol, Acebutolol, Carvedilol, Nebivolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Oct 2022 (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.
Investigators will determine whether N-of-1 trials, as a pragmatic, participant-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased participant confidence regarding their preference to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).
Detailed description
This is an unblinded NIH Stage I of Behavioral Intervention Development trial, using serial multiple-period single participant crossover design. Investigators will enroll 20 participants, conducting an N-of-1 trial in each. The intervention is a two-arm crossover withdrawal/reversal design (On [A] vs. Off [B]) with up to 6 periods, each period lasting up to 6 weeks. The sequence of treatment will be randomized to either ABAB or BABA. Each participant will have the option to participate in additional (no more than 6) periods if they wish to gather more data. The intervention drug will be beta-blockers, previously prescribed to the participants by their physician. The investigators have developed a titration algorithm, where during the On period (A), participants will be on their baseline beta-blocker dose (or the highest dose they can safely tolerate). During the Off period (B), their beta-blockers will be down-titrated and subsequently discontinued (or at the lowest dose they can safely tolerate); we will decrease the dose of the beta-blocker by 50% every week regardless of which beta-blocker they are on. When returning to On, from Off, we will up-titrate by 50% until reaching their home dose (or the highest dose they can safely tolerate).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-Blocker ABAB Sequence | Active comparator | Drug: Beta blockerThis arm will follow an ABAB sequence: ON beta-blockers (A) and OFF beta-blockers (B). Participants start with their home beta-blocker dose in Period 1 (A), and then switch to Period 2 (B), where the dose is slowly reduced until they are off their beta-blocker (or the lowest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information to make a preference. These extra phases follow the same ON-OFF pattern (ABABAB), meaning if the participant chooses to continue into Period 3 (A), the study team will restart the participant's beta-blocker, and slowly up-titrate until they reach their home dose, or their highest tolerable dose. This continues until the participant has enough information to clarify their preference about their beta-blocker, with a limit of 6 periods. |
| Beta-Blocker BABA Sequence | Active comparator | Drug: Beta blockerThis arm will follow a BABA sequence: OFF beta-blockers (B) and ON beta-blockers (A). Participants start Period 1 (B) by slowly reducing the participant's beta-blocker home dose by 50% each week until they are off (or the lowest tolerable dose), then switch to Period 2 (A), where they restart their beta-blocker and slowly up-titrate until they reach their home dose (or the highest tolerable dose). Participants are then asked if they have enough information to clarify their preference about continuing or discontinuing their beta-blocker. Participants can choose to engage in 2-6 periods based on whether they need more information. The extra phases follow the same OFF-ON pattern (BABABA), meaning if they choose to continue into Period 3 (B), the participant will slowly reduce their beta-blocker until they are off (or the lowest tolerable dose). This continues until the participant has enough information to clarify their preference about their beta-blocker, with a max of 6 periods. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)
- Taking beta-blocker
Key exclusion criteria (29 listed)
- Alternate cause(s) of HFpEF Syndrome:
- Other compelling indication(s) for beta-blocker
- Clinical instability (N-of-1 trials are appropriate for stable conditions only)
- Estimated life expectancy < 6 months
- Moderate-severe dementia or psychiatric disorder precluding informed consent
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 blockerAlso: ABABThe intervention is a two-arm crossover withdrawal/reversal design (On [A] vs Off [B]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose). Participants will be randomized into either ABAB or BABA sequences. Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol | Drug | Beta-Blocker ABAB Sequence |
| Beta blockerAlso: BABAThe intervention is a two-arm crossover withdrawal/reversal design (On [A] vs Off [B]) with up to 6 periods, each period lasting up to 6 weeks. During the On period (A), participants will be on their home beta-blocker (or highest tolerable) dose. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued (or the lowest tolerable dose). Participants will be randomized into either ABAB or BABA sequences. Other names: acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol | Drug | Beta-Blocker BABA Sequence |
Primary outcome
Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews
Time frame: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.
Qualitative interviews will be conducted to assess the change in confidence through their experience participating in N-of-1 trials. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.
Change in participant decision-confidence, as measured by the Decisional Conflict Scale (DCS)
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Measures participant perceptions of uncertainty in decision-making, factors contributing to uncertainty, and effective decision-making. A set of 16 questions with responses ranging from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 and 100. Lower scores indicate feeling informed and low decisional conflict whereas higher scores indicate feelings of uncertainty and high decisional conflict.
7 secondary outcomes
Features of a feasible and pragmatic protocol for deprescribing N-of-1 trials in participants with Heart Failure with Preserved Ejection Fraction, as measured by qualitative interviews.
Time frame: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.
Change in participants feeling informed through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants feeling uncertainty through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants feeling supported through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participants decision effectiveness through an N-of-1 protocol, as measured by the Decisional Conflict sub-scale
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in shared decision making through an N-of-1 protocol, as measured by the 9-item Shared Decision-Making Questionnaire
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Change in participant activation through an N-of-1 protocol, as assessed by the Patient Activation Measure (PAM)
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
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 Aug 2026.
- 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 contact
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 blocker in people with Heart Failure and Heart Failure, Diastolic, 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 2 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?
Contact Srikar Savaram, BS (646-962-7919, pro4001@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews (time frame: From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.). The study lists 2 primary outcomes in all. 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 Aug 2026.