RecruitingPhase 4NCT05585125

A Preliminary Study for INFORMED

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


Sponsor

Weill Medical College of Cornell University

Enrollment

18 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Beta blocker and a drug called Beta blocker for people with cardiac failure, heart diseases, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBeta 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

DRUGBeta 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


Locations(1)

Weill Cornell Medicine

New York, New York, United States

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NCT05585125


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