CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
Beta blockersdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04757584
NCT04757584Phase 4Completed

N-of-1 Trials for Deprescribing Beta-blockers in HFpEF

Weill Medical College of Cornell University·interventional·Posted Feb 17, 2021·Updated Apr 9, 2024

In Brief

A Phase 4 clinical trial evaluating Beta blockers for Heart Failure and 4 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed Summary

In this study, we will test the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective we will conduct 16 4-period N-of-1 trials (on vs. off) and subsequently interview participants to better understand feasibility and pragmatism. The N-of-1 trials will be iteratively refined in real-time based on this feedback.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedFeb 17, 2021
Enrollment StartApr 1, 2021
Primary CompletionApr 28, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Beta blockersdrug

The intervention is a two-arm crossover withdrawal/ reversal design (On \[A\] vs Off \[B\]) with up to 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued. Subjects will be randomized into either ABAB or BABA sequences.