[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484214":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":39,"enrollmentInfo":77,"targetDuration":39,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":46,"whyStopped":39,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Beta blocker",{"label":15,"type":10,"description":16,"interventionNames":17},"Beta-Blocker BABA Sequence","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.",[13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Beta blocker","The intervention is a two-arm crossover withdrawal\u002Freversal 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).\n\nParticipants will be randomized into either ABAB or BABA sequences.\n\nOther names:\n\nacebutolol, atenolol, betaxolol, bisoprolol, carvedilol, labetalol, metoprolol, metoprolol succinate, metoprolol tartrate, nadolol, nebivolol, propranolol, penbutolol, pindolol, propranolol",[9],[25],"ABAB",{"type":20,"name":21,"description":22,"armGroupLabels":27,"otherNames":28},[15],[29],"BABA",[31],{"name":32,"affiliation":5,"role":33},"Parag Goyal, MD, MSc","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Srikar Savaram, BS","CONTACT","646-962-7919",null,"pro4001@med.cornell.edu",{"name":32,"role":37,"phone":39,"phoneExt":39,"email":42},"pag9051@med.cornell.edu",[44],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Weill Cornell Medicine","RECRUITING","New York","10065","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.00597,40.71427,{"lat":55,"lon":54},[58,60],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":59},"srs4011@med.cornel.edu",{"name":32,"role":33,"phone":39,"phoneExt":39,"email":39},{"type":62,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[64],{"name":65,"class":66},"National Institute on Aging (NIA)","NIH","100484214","phase-4-a-preliminary-study-for-informed-100484214",false,"NCT05585125","A Preliminary Study for INFORMED","A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization","PRE-INFORMED","Inclusion Criteria:\n\n1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC\u002FAHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%)\n2. Taking beta-blocker\n\nExclusion Criteria:\n\n1. Alternate cause(s) of HFpEF Syndrome:\n\n   1. Severe aortic stenosis\n   2. Moderate-severe mitral stenosis\n   3. Constrictive pericarditis\n   4. High output HF\n   5. Infiltrative cardiomyopathy\n2. Other compelling indication(s) for beta-blocker\n\n   1. Prior EF \\\u003C 50%\n   2. Hypertrophic cardiomyopathy\n   3. Angina\n   4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years\n   5. History of ventricular tachycardia\u002Farrhythmia\n   6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year\n   7. Heart rate \\>100 bpm within the prior 3 months\n   8. Atrial arrhythmia with ventricular rate \\>90 per minute in the prior 3 months\n   9. Systolic blood pressure readings \\>160 mmHg within the prior 3 months, unless classified as white coat hypertension\u002Feffect (and home blood pressures below 140 mmHg)\n   10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction)\n3. Clinical instability (N-of-1 trials are appropriate for stable conditions only)\n\n   1. Decompensated heart failure\n   2. Hospitalization in the past 30 days\n   3. Medication changes or procedures in the prior 14 days that could confound observations\u002Fdata at PI discretion\n   4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations\u002Fdata at PI discretion\n   5. Clinical instability from other medical issues\n4. Estimated life expectancy \\\u003C 6 months\n5. Moderate-severe dementia or psychiatric disorder precluding informed consent\n6. Language barrier that will preclude informed consent and ability to comprehend study procedures\n7. Non-compliance or inability to complete study procedures\n8. Enrollment in a clinical trial not approved for co-enrollment\n9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation","ALL","65 Years",{"count":78,"type":79},18,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","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).",[85,86,87,88,89],"Heart Failure","Heart Failure, Diastolic","Heart Failure With Preserved Ejection Fraction","Cardiac Failure","Heart Diseases",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"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","Antihypertensive Agents","Vasodilator Agents","Sympatholytics","Autonomic Agents","Peripheral Nervous System Agents","Adrenergic beta-1 Receptor Antagonists","2026-08-19",{"date":119,"type":120},"2026-08-21","ACTUAL",{"date":122,"type":120},"2024-02-07",{"date":124,"type":79},"2027-11",{"name":5,"class":6},1]