A Phase 4 interventional study of Beta blocker and Beta blocker in Heart Failure, Heart Failure, Diastolic and Heart Failure With Preserved Ejection Fraction, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Other
Among 95 studies in Heart Failure, Diastolic with a site in United States — 18 open to participants now, 20 under way, none of them phase 3. Heart Failure, Diastolic · United States.
Among the 95 studies in Heart Failure, Diastolic with a site in United States, this one is the 56th largest by planned enrollment of the 81 interventional ones that give a count, is one of 4 that started in 2024, is one of 17 in phase 4, reaches primary completion later than 7 of the 19 other live ones, and was the 77th registered.
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
Browse Heart Failure, Diastolic studies →18 of the 95 studies in Heart Failure, Diastolic with a site in United States are open now. Recruiting first, the newest first:
Tufts Medical Center · Sites in United States
Ages 18+
Eli Lilly and Company · Sites in United States, Japan, Moldova and 2 more countries
Ages 18–65
Columbia University · Sites in United States
Ages 40+
University of Virginia · Sites in United States
Ages 18–90
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Heart Failure, Diastolic studies recruiting now, 21 (72%) set no upper age limit and 4 (14%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 15 · Phase 3 4 · Phase 4 17
First in 2003; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 18 is below the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.
Median enrollment 36 across the 81 interventional studies, 80 across the 14 observational. Of the 70 that completed or were terminated, 34 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 95 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 3 studies filed under Heart Failure, Diastolic — fewer than ten, so there is no comparison to draw.
6 of the studies in Heart Failure, Diastolic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06009276University of VirginiaAssociations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status | 2026-12 |
| NCT05585125Weill Medical College of Cornell UniversityA Preliminary Study for INFORMED | 2027-02 |
| NCT06937320Duke UniversityChronic Exogenous Ketosis in HFpEF | 2027-06 |
| NCT05425459Corvia MedicalRESPONDER-HF Trial | 2027-07 |
| NCT07057323Mayo ClinicCoronary Sinus Reducer For The Management Of Symptomatic Heart Failure | 2027-08 |
Add all 6 to your calendar (.ics) → With an account.
Among the 95 studies in Heart Failure, Diastolic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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).
199 studies on the registry are indexed under Heart Failure, Diastolic; 44 are open to participants now.
This study's planned enrollment of 18 is below the median of 48 across 139 interventional studies indexed under Heart Failure, Diastolic.
Browse Heart Failure, Diastolic studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Compared within Heart Failure, Diastolic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Failure. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Beta blocker
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.
Drug: Beta blocker
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
Also known as: 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
Also known as: BABA
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.
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 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.
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
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.
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
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).
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
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).
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
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).
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
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).
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
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).
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)
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.
Time frame: From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.
Plan to share: No
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Started Feb 2024 (actual). Primary completion is estimated for Feb 2027, 36 months after the start.
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Studies of the drug tested here: Beta blockers
Weill Medical College of Cornell University →