A Preliminary Study for INFORMED

ENROLLING BY INVITATION

NCT05585125

PHASE4

Sponsor: Weill Medical College of Cornell University

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 Failure with Preserved Ejection Fraction (HFpEF).

Official title: A Preliminary Study for the Intervention of an N-of-1 Protocol For Medication Optimization

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-02-07

Completion Date

2026-07

Last Updated

2025-10-23

Healthy Volunteers

No

Conditions

Heart Failure Heart Failure, Diastolic Heart Failure With Preserved Ejection Fraction Cardiac Failure Heart Diseases

Interventions

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

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

Inclusion Criteria: 1. Ambulatory adults age ≥ 65 years with HFpEF, according to ACC/AHA guidelines (signs and symptoms of heart failure AND ejection fraction ≥ 50%) 2. Taking beta-blocker Exclusion Criteria: 1. Alternate cause(s) of HFpEF Syndrome: 1. Severe aortic stenosis 2. Moderate-severe mitral stenosis 3. Constrictive pericarditis 4. High output HF 5. Infiltrative cardiomyopathy 2. Other compelling indication(s) for beta-blocker 1. Prior EF \< 50% 2. Hypertrophic cardiomyopathy 3. Angina 4. Acute coronary syndrome, myocardial infarction, or coronary artery bypass surgery in prior 3 years 5. History of ventricular tachycardia/arrhythmia 6. Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year 7. Heart rate \>100 bpm within the prior 3 months 8. Atrial arrhythmia with ventricular rate \>90 per minute in the prior 3 months 9. 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) 10. Non-cardiac indications (e.g., migraine prevention, anxiety symptom management, hyperthyroidism, essential tumor reduction) 3. Clinical instability (N-of-1 trials are appropriate for stable conditions only) 1. Decompensated heart failure 2. Hospitalization in the past 30 days 3. Medication changes or procedures in the prior 14 days that could confound observations/data at PI discretion 4. Anticipated medication changes or procedures in subsequent 3 months that could confound observations/data at PI discretion 5. Clinical instability from other medical issues 4. Estimated life expectancy \< 6 months 5. Moderate-severe dementia or psychiatric disorder precluding informed consent 6. Language barrier that will preclude informed consent and ability to comprehend study procedures 7. Non-compliance or inability to complete study procedures 8. Enrollment in a clinical trial not approved for co-enrollment 9. Any condition that, in the Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation

Locations (1)

Weill Cornell Medicine

New York, New York, United States

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